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CompletedNCT02963649Updated Jul 8, 2025Results posted

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

An interventional study of DCB and PTA in Critical Limb Ischemia and Peripheral Arterial Disease, sponsored by Medtronic Endovascular. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Medtronic Endovascular · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.

02

Conditions studied

  • Critical Limb Ischemia
  • Peripheral Arterial Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years.
  2. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
  3. Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
  4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
  5. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
  6. Life expectancy >1 year in the Investigator's opinion.
  7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
  8. Total occlusions with total lesion length ≥ 40 mm (by visual estimate).
  9. Lesion must be located in the infrapopliteal arteries and above the ankle joint.
  10. Multiple lesions can be treated if located in separate vessels.
  11. Presence of documented run-off to the foot.
  12. Inflow free from flow-limiting lesion confirmed by angiography.
  13. Successful pre-dilatation of the (entire) target lesion.

Exclusion criteria

Exclusion Criteria:

  1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
  2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
  3. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
  4. Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
  5. Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
  6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
  7. Previous DCB procedure in the target vessel within 6 months prior to index procedure.
  8. Aneurysm in the target vessel.
  9. Angiographic evidence of thrombus within target limb.
  10. Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis > 30%.
  11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
  12. Recent MI or stroke \< 30 days prior to the index procedure.
  13. Heart failure with Ejection Fraction \< 30%.
  14. Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
  15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
  16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
  17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
  18. Impaired renal function (GFR \<20 mL/min) and patients on dialysis.
  19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
  20. Patient receiving systemic corticosteroid therapy.
  21. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
  22. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
  23. Female subjects who are breastfeeding at the time of enrollment.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Drug Coated Balloon IN.PACT 014 (DCB)

    Participants who receive IN.PACT 014.

    Device: DCB

  • Active comparator
    Percutaneous Transluminal Angioplasty (PTA)

    Participants who receive standard PTA treatment.

    Device: PTA

Interventions

  • DeviceDCB

    Drug Coated Balloon

  • DevicePTA

    Percutaneous Transluminal Angioplasty

05

What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months

    Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months

    Time frame: 9 Months

Secondary outcomes

  1. Composite Safety Endpoint

    A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure

    Time frame: 9 Months

  2. Major Adverse Event (MAE) Rate

    defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months

  3. Functional Flow Assessment

    is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.

    Time frame: at 3, 6, 9, 12, 24 and 36 months

  4. Death of Any Cause

    Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months

  5. Major Target Limb Amputation Rate

    Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months

  6. Clinically-driven Target Lesion Revascularization (CD-TLR) Rate

    Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months

  7. Mechanically-driven Target Lesion Revascularization (TLR) Rate

    Mechanically-driven Target Lesion Revascularization (TLR) rate

    Time frame: through 37 days

  8. Target Lesion Revascularization (TLR) Rate

    Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months

  9. Clinically-driven Target Vessel Revascularization (CD-TVR) Rate

    Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months

  10. Target Vessel Revascularization (TVR) Rate

    Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months

  11. Status of Wound Healing

    Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm

    Time frame: at 30 days, 3, 6, 9, 12, 24 and 36 months

  12. Rate of Thrombosis at the Target Lesion

    Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months

    Time frame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months

  13. Device Success

    Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study

    Time frame: at the time of procedure

  14. Clinical Success

    Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis \> 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed.

    Time frame: up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.]

06

Results

Posted Jul 8, 2025

Participant flow

Participant flow — Overall Study
MilestoneDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Started2327
Completed1116
Not completed1211

Outcome measures

PrimaryPrimary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months

Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months

Time frame:
9 Months
Reported as:
Mean · mm
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months
mmDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months0.892 ± 0.7741.312 ± 0.720
SecondaryComposite Safety Endpoint

A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure

Time frame:
9 Months
Reported as:
Count of participants · Participants
Composite Safety Endpoint
ParticipantsDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Composite Safety Endpoint2121
SecondaryMajor Adverse Event (MAE) Rate

defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Major Adverse Event (MAE) Rate
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
through 3 months95.45 (87.14 to 100)96.30 (89.43 to 100)
through 6 months95.45 (87.14 to 100)88.89 (77.79 to 100)
through 9 months86.36 (73.15 to 100)85.19 (72.79 to 99.70)
through 12 months81.82 (67.19 to 99.63)77.78 (63.58 to 95.15)
through 24 months54.55 (37.25 to 79.88)70.37 (55.09 to 89.88)
through 36 months45.45 (28.76 to 71.84)62.96 (47.15 to 84.09)
through 48 months45.45 (28.76 to 71.84)51.16 (35.23 to 74.28)
through 60 months45.45 (28.76 to 71.84)46.89 (31.12 to 70.67)
SecondaryFunctional Flow Assessment

is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.

Time frame:
at 3, 6, 9, 12, 24 and 36 months
Reported as:
Count of units · Lesions
Functional Flow Assessment
LesionsDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
At 3 Months1514
At 6 Months1513
At 9 Months116
At 12 Months115
At 24 Months610
At 36 Months96
SecondaryDeath of Any Cause

Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Death of Any Cause
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 3 months100.0 (100.0 to 100.0)96.30 (89.43 to 100.0)
Through 6 months100.0 (100.0 to 100.0)92.59 (83.22 to 100.0)
Through 9 months95.45 (87.14 to 100.0)92.59 (83.22 to 100.0)
Through 12 months95.45 (87.14 to 100.0)88.89 (77.79 to 100.0)
Through 24 months72.73 (56.31 to 93.94)88.89 (77.79 to 100.0)
Through 36 months68.18 (51.25 to 90.71)77.78 (63.58 to 95.15)
Through 48 months59.09 (41.74 to 83.66)73.89 (58.98 to 92.56)
Through 60 months59.09 (41.74 to 83.66)65.68 (49.72 to 86.75)
SecondaryMajor Target Limb Amputation Rate

Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Major Target Limb Amputation Rate
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 30 days100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 3 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 6 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 9 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 12 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 24 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 36 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 48 months100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)
Through 60 months100.00 (100.00 to 100.00)93.75 (82.61 to 100.00)
SecondaryClinically-driven Target Lesion Revascularization (CD-TLR) Rate

Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 3 months95.45 (87.14 to 100.00)100.00 (100.00 to 100.00)
Through 6 months95.45 (87.14 to 100.00)96.15 (89.04 to 100.00)
Through 9 months90.68 (79.17 to 100.00)92.15 (82.27 to 100.00)
Through 12 months85.91 (72.32 to 100.00)88.14 (76.39 to 100.00)
Through 24 months80.86 (65.59 to 99.67)79.75 (65.34 to 97.33)
Through 36 months73.51 (55.52 to 97.31)79.75 (65.34 to 97.33)
Through 48 months73.51 (55.52 to 97.31)69.78 (53.16 to 91.60)
Through 60 months73.51 (55.52 to 97.31)69.78 (53.16 to 91.60)
SecondaryMechanically-driven Target Lesion Revascularization (TLR) Rate

Mechanically-driven Target Lesion Revascularization (TLR) rate

Time frame:
through 37 days
Reported as:
Count of participants · Participants
Mechanically-driven Target Lesion Revascularization (TLR) Rate
ParticipantsDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Mechanically-driven Target Lesion Revascularization (TLR) Rate10
SecondaryTarget Lesion Revascularization (TLR) Rate

Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Target Lesion Revascularization (TLR) Rate
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 3 months95.65 (87.67 to 100.00)100.00 (100.00 to 100.00)
Through 6 months95.65 (87.67 to 100.00)96.15 (89.04 to 100.00)
Through 9 months90.87 (79.55 to 100.00)84.13 (71.01 to 99.69)
Through 12 months86.09 (72.62 to 100.00)80.13 (65.95 to 97.35)
Through 24 months81.02 (65.84 to 99.71)71.69 (55.92 to 91.91)
Through 36 months73.66 (55.71 to 97.38)71.69 (55.92 to 91.91)
Through 48 months73.66 (55.71 to 97.38)62.13 (45.21 to 85.39)
Through 60 months73.66 (55.71 to 97.38)62.13 (45.21 to 85.39)
SecondaryClinically-driven Target Vessel Revascularization (CD-TVR) Rate

Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 3 months95.45 (87.14 to 100.00)96.15 (89.04 to 100.00)
Through 6 months95.45 (87.14 to 100.00)92.31 (82.61 to 100.00)
Through 9 months90.68 (79.17 to 100.00)88.29 (76.68 to 100.00)
Through 12 months85.91 (72.32 to 100.00)84.28 (71.25 to 99.70)
Through 24 months80.86 (65.59 to 99.67)75.85 (60.71 to 94.77)
Through 36 months73.51 (55.52 to 97.31)75.85 (60.71 to 94.77)
Through 48 months73.51 (55.52 to 97.31)65.74 (48.79 to 88.58)
Through 60 months73.51 (55.52 to 97.31)65.74 (48.79 to 88.58)
SecondaryTarget Vessel Revascularization (TVR) Rate

Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Target Vessel Revascularization (TVR) Rate
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 3 months95.65 (87.67 to 100.00)96.15 (89.04 to 100.00)
Through 6 months95.65 (87.67 to 100.00)92.31 (82.61 to 100.00)
Through 9 months90.87 (79.55 to 100.00)80.27 (66.16 to 97.38)
Through 12 months86.09 (72.62 to 100.00)76.25 (61.32 to 94.82)
Through 24 months81.02 (65.84 to 99.71)67.78 (51.62 to 89.00)
Through 36 months73.66 (55.71 to 97.38)67.78 (51.62 to 89.00)
Through 48 months73.66 (55.71 to 97.38)58.10 (41.10 to 82.14)
Through 60 months73.66 (55.71 to 97.38)58.10 (41.10 to 82.14)
SecondaryStatus of Wound Healing

Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm

Time frame:
at 30 days, 3, 6, 9, 12, 24 and 36 months
Reported as:
Count of units · Baseline wounds
Status of Wound Healing
Baseline woundsDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Within 30 Days — Completely Healed32
Within 30 Days — Improvement78
Within 30 Days — Unchanged03
Within 30 Days — Worsened01
Within 30 Days — Amputation1111
Within 30 Days — Skin graft00
Within 3 Months — Completely Healed57
Within 3 Months — Improvement44
Within 3 Months — Unchanged02
Within 3 Months — Worsened10
Within 3 Months — Amputation1111
Within 3 Months — Skin graft00
Within 6 Months — Completely Healed810
Within 6 Months — Improvement20
Within 6 Months — Unchanged01
Within 6 Months — Worsened01
Within 6 Months — Amputation1112
Within 6 Months — Skin graft00
Within 9 Months — Completely Healed910
Within 9 Months — Improvement11
Within 9 Months — Unchanged01
Within 9 Months — Worsened00
Within 9 Months — Amputation1111
Within 9 Months — Skin graft00
Within 12 Months — Completely Healed810
Within 12 Months — Improvement10
Within 12 Months — Unchanged02
Within 12 Months — Worsened00
Within 12 Months — Amputation1111
Within 12 Months — Skin graft00
Within 24 Months — Completely Healed89
Within 24 Months — Improvement10
Within 24 Months — Unchanged02
Within 24 Months — Worsened00
Within 24 Months — Amputation1111
Within 24 Months — Skin graft00
Within 36 Months — Completely Healed69
Within 36 Months — Improvement00
Within 36 Months — Unchanged02
Within 36 Months — Worsened00
Within 36 Months — Amputation711
Within 36 Months — Skin graft00
SecondaryRate of Thrombosis at the Target Lesion

Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months

Time frame:
through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Reported as:
Number · probability
Rate of Thrombosis at the Target Lesion
probabilityDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Through 30 days95.7 (87.6 to 100.0)96.3 (89.4 to 100.0)
Through 3 months95.7 (87.6 to 100.0)96.3 (89.4 to 100.0)
Through 6 months95.7 (87.6 to 100.0)96.3 (89.4 to 100.0)
Through 9 months95.7 (87.6 to 100.0)96.3 (89.4 to 100.0)
Through 12 months90.9 (79.5 to 100.0)96.3 (89.4 to 100.0)
Through 24 months86.1 (72.6 to 100.0)96.3 (89.4 to 100.0)
Through 36 months86.1 (72.6 to 100.0)96.3 (89.4 to 100.0)
Through 48 months86.1 (72.6 to 100.0)96.3 (89.4 to 100.0)
Through 60 months86.1 (72.6 to 100.0)96.3 (89.4 to 100.0)
SecondaryDevice Success

Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study

Time frame:
at the time of procedure
Reported as:
Count of units · IN.PACT 014 Investigational devices
Device Success
IN.PACT 014 Investigational devicesDrug Coated Balloon IN.PACT 014
Device Success64
SecondaryClinical Success

Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis \> 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed.

Time frame:
up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.]
Reported as:
Count of participants · Participants
Clinical Success
ParticipantsDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
Clinical Success1211

Adverse events

Collected over 1800 Days (60 Months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Drug Coated Balloon IN.PACT 0149/23 (39.1%)19/23 (82.6%)13/23 (56.5%)
Percutaneous Transluminal Angioplasty (PTA)9/27 (33.3%)25/27 (92.6%)24/27 (88.9%)
Most frequent serious events
Showing 10 of 81
Most frequent serious events
EventDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
PERIPHERAL ARTERIAL REOCCLUSIONInjury, poisoning and procedural complications3/238/27
PERIPHERAL ARTERY OCCLUSIONVascular disorders5/238/27
ISCHAEMIC SKIN ULCERSkin and subcutaneous tissue disorders1/236/27
CARDIAC FAILURECardiac disorders5/232/27
PERIPHERAL ARTERY THROMBOSISVascular disorders4/232/27
LIMB INJURYInjury, poisoning and procedural complications2/234/27
PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications3/234/27
PERIPHERAL ARTERY STENOSISVascular disorders2/234/27
WOUND DEHISCENCEInjury, poisoning and procedural complications3/231/27
SKIN ULCERSkin and subcutaneous tissue disorders3/232/27
Most frequent other events
Most frequent other events
EventDrug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)
PERIPHERAL ARTERIAL REOCCLUSIONInjury, poisoning and procedural complications2/236/27
PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications2/235/27
LIMB INJURYInjury, poisoning and procedural complications0/234/27
SKIN ULCERSkin and subcutaneous tissue disorders0/233/27
PERIPHERAL ARTERY OCCLUSIONVascular disorders2/233/27
PERIPHERAL ARTERY ANEURYSMVascular disorders2/230/27
PERIPHERAL ARTERY DISSECTIONVascular disorders2/230/27
PERIPHERAL ARTERY STENOSISVascular disorders2/231/27
IMPAIRED HEALINGGeneral disorders1/232/27

Baseline characteristics

Study sites identified 25 target lesions in the IN.PACT 014 group and 30 in the PTA group. All site-reported lesion characteristics use 25 as the denominator for the IN.PACT 014 group and 30 as the denominator for the PTA group. CoreLab identified 24 target lesions in the IN.PACT 014 group and 29 in the PTA group. Therefore, all CoreLab reported lesion characteristics use 24 as the denominator for the IN.PACT 014 group and 29 as the denominator for the PTA group.

Age, Continuous
Age, Continuous(Years)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Mean73.1 ± 7.469.6 ± 9.471.20 ± 8.60
Sex: Female, Male
Sex: Female, Male(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Female4711
Male192039
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Count of participants——0
Obesity, BMI >=30kg/m2
Obesity, BMI >=30kg/m2(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Count of participants5712
Diabetes Mellitus
Diabetes Mellitus(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Count of participants172643
Diabetes Mellitus Insulin-dependent
Diabetes Mellitus Insulin-dependent(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Count of participants92029
Hypertension
Hypertension(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Count of participants192140
Hyperlipideamia
Hyperlipideamia(Participants)Drug Coated Balloon IN.PACT 014Percutaneous Transluminal Angioplasty (PTA)Total
Count of participants162036

33 further baseline measures are reported on the registry.

07

Study locations

9 sites
  • AZ Sint Blasius
    Dendermonde, East-Flanders 9200, Belgium
  • ZOL Genk
    Genk, Limburg 3600, Belgium
  • Universitair Ziekenhuis Gent
    Ghent, 9000, Belgium
  • Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire
    Nantes, France
  • University Hospital Patras
    Pátrai, Greece
  • IRCCS Multimedica
    Sesto San Giovanni, Lombardy 20099, Italy
  • Maria Cecilia Hospital
    Cotignola, Ravenna 48033, Italy
  • Ospedale San Donato
    Arezzo, 50200, Italy
  • University Hospital Zurich
    Zurich, Switzerland
08

References and documents

Publications

  • Liistro F, Weinberg I, Almonacid Popma A, Shishehbor MH, Deckers S, Micari A. Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial. EuroIntervention. 2022 Apr 1;17(17):e1445-e1454. doi: 10.4244/EIJ-D-21-00444. PubMed 34602386 ↗

Study documents

  • Study protocol · Jun 11, 2020
  • Statistical analysis plan · Jan 24, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT02963649
Lead sponsor
Medtronic Endovascular
Responsible party
Sponsor
First posted
Nov 15, 2016
Start date
Mar 2, 2017
Primary completion
Oct 7, 2019
Completion
Dec 21, 2023
Results posted
Jul 8, 2025
Last update
Jul 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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