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 (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 239 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Medtronic Endovascular is the lead sponsor of 51 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who receive IN.PACT 014.
Device: DCB
Participants who receive standard PTA treatment.
Device: PTA
Drug Coated Balloon
Percutaneous Transluminal Angioplasty
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
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
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
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
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
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
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
Mechanically-driven Target Lesion Revascularization (TLR) Rate
Mechanically-driven Target Lesion Revascularization (TLR) rate
Time frame: through 37 days
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
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
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
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
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
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
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.]
| Milestone | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Started | 23 | 27 |
| Completed | 11 | 16 |
| Not completed | 12 | 11 |
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
| mm | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months | 0.892 ± 0.774 | 1.312 ± 0.720 |
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
| Participants | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Composite Safety Endpoint | 21 | 21 |
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
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| through 3 months | 95.45 (87.14 to 100) | 96.30 (89.43 to 100) |
| through 6 months | 95.45 (87.14 to 100) | 88.89 (77.79 to 100) |
| through 9 months | 86.36 (73.15 to 100) | 85.19 (72.79 to 99.70) |
| through 12 months | 81.82 (67.19 to 99.63) | 77.78 (63.58 to 95.15) |
| through 24 months | 54.55 (37.25 to 79.88) | 70.37 (55.09 to 89.88) |
| through 36 months | 45.45 (28.76 to 71.84) | 62.96 (47.15 to 84.09) |
| through 48 months | 45.45 (28.76 to 71.84) | 51.16 (35.23 to 74.28) |
| through 60 months | 45.45 (28.76 to 71.84) | 46.89 (31.12 to 70.67) |
is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.
| Lesions | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| At 3 Months | 15 | 14 |
| At 6 Months | 15 | 13 |
| At 9 Months | 11 | 6 |
| At 12 Months | 11 | 5 |
| At 24 Months | 6 | 10 |
| At 36 Months | 9 | 6 |
Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 3 months | 100.0 (100.0 to 100.0) | 96.30 (89.43 to 100.0) |
| Through 6 months | 100.0 (100.0 to 100.0) | 92.59 (83.22 to 100.0) |
| Through 9 months | 95.45 (87.14 to 100.0) | 92.59 (83.22 to 100.0) |
| Through 12 months | 95.45 (87.14 to 100.0) | 88.89 (77.79 to 100.0) |
| Through 24 months | 72.73 (56.31 to 93.94) | 88.89 (77.79 to 100.0) |
| Through 36 months | 68.18 (51.25 to 90.71) | 77.78 (63.58 to 95.15) |
| Through 48 months | 59.09 (41.74 to 83.66) | 73.89 (58.98 to 92.56) |
| Through 60 months | 59.09 (41.74 to 83.66) | 65.68 (49.72 to 86.75) |
Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 30 days | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 3 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 6 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 9 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 12 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 24 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 36 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 48 months | 100.00 (100.00 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 60 months | 100.00 (100.00 to 100.00) | 93.75 (82.61 to 100.00) |
Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 3 months | 95.45 (87.14 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 6 months | 95.45 (87.14 to 100.00) | 96.15 (89.04 to 100.00) |
| Through 9 months | 90.68 (79.17 to 100.00) | 92.15 (82.27 to 100.00) |
| Through 12 months | 85.91 (72.32 to 100.00) | 88.14 (76.39 to 100.00) |
| Through 24 months | 80.86 (65.59 to 99.67) | 79.75 (65.34 to 97.33) |
| Through 36 months | 73.51 (55.52 to 97.31) | 79.75 (65.34 to 97.33) |
| Through 48 months | 73.51 (55.52 to 97.31) | 69.78 (53.16 to 91.60) |
| Through 60 months | 73.51 (55.52 to 97.31) | 69.78 (53.16 to 91.60) |
Mechanically-driven Target Lesion Revascularization (TLR) rate
| Participants | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Mechanically-driven Target Lesion Revascularization (TLR) Rate | 1 | 0 |
Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 3 months | 95.65 (87.67 to 100.00) | 100.00 (100.00 to 100.00) |
| Through 6 months | 95.65 (87.67 to 100.00) | 96.15 (89.04 to 100.00) |
| Through 9 months | 90.87 (79.55 to 100.00) | 84.13 (71.01 to 99.69) |
| Through 12 months | 86.09 (72.62 to 100.00) | 80.13 (65.95 to 97.35) |
| Through 24 months | 81.02 (65.84 to 99.71) | 71.69 (55.92 to 91.91) |
| Through 36 months | 73.66 (55.71 to 97.38) | 71.69 (55.92 to 91.91) |
| Through 48 months | 73.66 (55.71 to 97.38) | 62.13 (45.21 to 85.39) |
| Through 60 months | 73.66 (55.71 to 97.38) | 62.13 (45.21 to 85.39) |
Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 3 months | 95.45 (87.14 to 100.00) | 96.15 (89.04 to 100.00) |
| Through 6 months | 95.45 (87.14 to 100.00) | 92.31 (82.61 to 100.00) |
| Through 9 months | 90.68 (79.17 to 100.00) | 88.29 (76.68 to 100.00) |
| Through 12 months | 85.91 (72.32 to 100.00) | 84.28 (71.25 to 99.70) |
| Through 24 months | 80.86 (65.59 to 99.67) | 75.85 (60.71 to 94.77) |
| Through 36 months | 73.51 (55.52 to 97.31) | 75.85 (60.71 to 94.77) |
| Through 48 months | 73.51 (55.52 to 97.31) | 65.74 (48.79 to 88.58) |
| Through 60 months | 73.51 (55.52 to 97.31) | 65.74 (48.79 to 88.58) |
Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 3 months | 95.65 (87.67 to 100.00) | 96.15 (89.04 to 100.00) |
| Through 6 months | 95.65 (87.67 to 100.00) | 92.31 (82.61 to 100.00) |
| Through 9 months | 90.87 (79.55 to 100.00) | 80.27 (66.16 to 97.38) |
| Through 12 months | 86.09 (72.62 to 100.00) | 76.25 (61.32 to 94.82) |
| Through 24 months | 81.02 (65.84 to 99.71) | 67.78 (51.62 to 89.00) |
| Through 36 months | 73.66 (55.71 to 97.38) | 67.78 (51.62 to 89.00) |
| Through 48 months | 73.66 (55.71 to 97.38) | 58.10 (41.10 to 82.14) |
| Through 60 months | 73.66 (55.71 to 97.38) | 58.10 (41.10 to 82.14) |
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
| Baseline wounds | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Within 30 Days — Completely Healed | 3 | 2 |
| Within 30 Days — Improvement | 7 | 8 |
| Within 30 Days — Unchanged | 0 | 3 |
| Within 30 Days — Worsened | 0 | 1 |
| Within 30 Days — Amputation | 11 | 11 |
| Within 30 Days — Skin graft | 0 | 0 |
| Within 3 Months — Completely Healed | 5 | 7 |
| Within 3 Months — Improvement | 4 | 4 |
| Within 3 Months — Unchanged | 0 | 2 |
| Within 3 Months — Worsened | 1 | 0 |
| Within 3 Months — Amputation | 11 | 11 |
| Within 3 Months — Skin graft | 0 | 0 |
| Within 6 Months — Completely Healed | 8 | 10 |
| Within 6 Months — Improvement | 2 | 0 |
| Within 6 Months — Unchanged | 0 | 1 |
| Within 6 Months — Worsened | 0 | 1 |
| Within 6 Months — Amputation | 11 | 12 |
| Within 6 Months — Skin graft | 0 | 0 |
| Within 9 Months — Completely Healed | 9 | 10 |
| Within 9 Months — Improvement | 1 | 1 |
| Within 9 Months — Unchanged | 0 | 1 |
| Within 9 Months — Worsened | 0 | 0 |
| Within 9 Months — Amputation | 11 | 11 |
| Within 9 Months — Skin graft | 0 | 0 |
| Within 12 Months — Completely Healed | 8 | 10 |
| Within 12 Months — Improvement | 1 | 0 |
| Within 12 Months — Unchanged | 0 | 2 |
| Within 12 Months — Worsened | 0 | 0 |
| Within 12 Months — Amputation | 11 | 11 |
| Within 12 Months — Skin graft | 0 | 0 |
| Within 24 Months — Completely Healed | 8 | 9 |
| Within 24 Months — Improvement | 1 | 0 |
| Within 24 Months — Unchanged | 0 | 2 |
| Within 24 Months — Worsened | 0 | 0 |
| Within 24 Months — Amputation | 11 | 11 |
| Within 24 Months — Skin graft | 0 | 0 |
| Within 36 Months — Completely Healed | 6 | 9 |
| Within 36 Months — Improvement | 0 | 0 |
| Within 36 Months — Unchanged | 0 | 2 |
| Within 36 Months — Worsened | 0 | 0 |
| Within 36 Months — Amputation | 7 | 11 |
| Within 36 Months — Skin graft | 0 | 0 |
Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months
| probability | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Through 30 days | 95.7 (87.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 3 months | 95.7 (87.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 6 months | 95.7 (87.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 9 months | 95.7 (87.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 12 months | 90.9 (79.5 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 24 months | 86.1 (72.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 36 months | 86.1 (72.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 48 months | 86.1 (72.6 to 100.0) | 96.3 (89.4 to 100.0) |
| Through 60 months | 86.1 (72.6 to 100.0) | 96.3 (89.4 to 100.0) |
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
| IN.PACT 014 Investigational devices | Drug Coated Balloon IN.PACT 014 |
|---|---|
| Device Success | 64 |
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.
| Participants | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| Clinical Success | 12 | 11 |
Collected over 1800 Days (60 Months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | 9/23 (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%) |
| Event | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| PERIPHERAL ARTERIAL REOCCLUSIONInjury, poisoning and procedural complications | 3/23 | 8/27 |
| PERIPHERAL ARTERY OCCLUSIONVascular disorders | 5/23 | 8/27 |
| ISCHAEMIC SKIN ULCERSkin and subcutaneous tissue disorders | 1/23 | 6/27 |
| CARDIAC FAILURECardiac disorders | 5/23 | 2/27 |
| PERIPHERAL ARTERY THROMBOSISVascular disorders | 4/23 | 2/27 |
| LIMB INJURYInjury, poisoning and procedural complications | 2/23 | 4/27 |
| PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications | 3/23 | 4/27 |
| PERIPHERAL ARTERY STENOSISVascular disorders | 2/23 | 4/27 |
| WOUND DEHISCENCEInjury, poisoning and procedural complications | 3/23 | 1/27 |
| SKIN ULCERSkin and subcutaneous tissue disorders | 3/23 | 2/27 |
| Event | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) |
|---|---|---|
| PERIPHERAL ARTERIAL REOCCLUSIONInjury, poisoning and procedural complications | 2/23 | 6/27 |
| PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications | 2/23 | 5/27 |
| LIMB INJURYInjury, poisoning and procedural complications | 0/23 | 4/27 |
| SKIN ULCERSkin and subcutaneous tissue disorders | 0/23 | 3/27 |
| PERIPHERAL ARTERY OCCLUSIONVascular disorders | 2/23 | 3/27 |
| PERIPHERAL ARTERY ANEURYSMVascular disorders | 2/23 | 0/27 |
| PERIPHERAL ARTERY DISSECTIONVascular disorders | 2/23 | 0/27 |
| PERIPHERAL ARTERY STENOSISVascular disorders | 2/23 | 1/27 |
| IMPAIRED HEALINGGeneral disorders | 1/23 | 2/27 |
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(Years) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Mean | 73.1 ± 7.4 | 69.6 ± 9.4 | 71.20 ± 8.60 |
| Sex: Female, Male(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 19 | 20 | 39 |
| Race and Ethnicity Not Collected(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Obesity, BMI >=30kg/m2(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Count of participants | 5 | 7 | 12 |
| Diabetes Mellitus(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Count of participants | 17 | 26 | 43 |
| Diabetes Mellitus Insulin-dependent(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Count of participants | 9 | 20 | 29 |
| Hypertension(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Count of participants | 19 | 21 | 40 |
| Hyperlipideamia(Participants) | Drug Coated Balloon IN.PACT 014 | Percutaneous Transluminal Angioplasty (PTA) | Total |
|---|---|---|---|
| Count of participants | 16 | 20 | 36 |
33 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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