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Not yet recruitingNCT07746362HELIX-PADUpdated Oct 21, 2026

IV-X Medical Peripheral Intravascular Lithotripsy Study for PAD

An interventional study of IV-X Medical IVL System in Peripheral Artery Disease (PAD), sponsored by IVX Medical. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by IVX Medical · Not applicable, Interventional, and Treatment

Updated Oct 21, 2026Now Not yet recruitingStart date moved+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment calcified peripheral arteries (iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries).

Read the detailed description

IV-X Medical is conducting a prospective, single-arm, multi-center clinical premarket study to evaluate the safety and effectiveness of the IV-X Medical IVL System to treat moderately to severely calcified peripheral arteries in the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries. Study cohorts will consist of an above-the-knee (ATK) cohort and, in parallel, below-the-knee (BTK) and long lesion (LL) cohorts. Approximately 140 subjects will be enrolled.

02

Conditions studied

  • Peripheral Artery Disease (PAD)

Keywords

  • PAD
  • IVL
  • Peripheral Artery Disease
  • Intravascular Lithotripsy
  • Lithotripsy
03

In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's planned enrollment of 140 is above the median of 73 across 1,078 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

IVX Medical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Eligibility criteria

Eligibility criteria are differentiated, where appropriate, by designated cohort. Subjects enrolled in the LL cohort are required to meet eligibility criteria for either the ATK or BTK cohorts, in addition to criteria set forth for the LL cohort.

Standard Inclusion Criteria:

  1. Age of subject is >18.

  2. Rutherford Clinical Category:

    1. ATK: 2, 3, or 4
    2. BTK: 4 or 5 (Category 5 will only include patients with ulcers not extending to the proximal metatarsal head)
  3. Estimated life expectancy >1 year in the opinion of the investigator at the time of enrollment.
  4. Subject or subject's legal representative agrees to participate and comply with the study assessments.

Angiographic Inclusion Criteria:

  1. Subject is a suitable candidate for angiography and endovascular intervention, in the opinion of the investigator or per hospital guideline.

  2. De novo target lesion that is located in a native vessel as follows:

    1. ATK: Iliac, superficial femoral artery (SFA), popliteal artery (extends to 2cm above the bifurcation or trifurcation of the tibial artery)
    2. BTK: distal segment (P3) of the popliteal artery to the top of the ankle joint
  3. Up to two (2) target lesion(s) in the target vessel.

  4. Target lesion reference vessel diameter is between the following sizes by visual estimate:

    1. ATK: 3.5mm and 12.0mm
    2. BTK: 2.0mm and 5.0mm

  5. Target lesion is the following total contiguous treatable length by investigator visual estimate and can be all or part of the zone:

    1. ATK and BTK: ≤180mm
    2. LL: >180mm (ATK or BTK)
  6. Target lesion stenosis ≥70% via visual estimate.

  7. Subject has at least:

    1. ATK: One (1) patent contiguous vessel with runoff to the foot (not supported by collateral circulation) in the target leg. Vessel patency is defined as no stenosis >50%.
    2. BTK: Distal reconstitution of one (1) pedal vessel (\<50% stenosis) (desert foot excluded).
  8. Ability to pass the guidewire intraluminally by Investigator evaluation across the atherosclerotic lesion, without the use of re-entry devices.
  9. Calcification is at least moderate with fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.
  10. Successful treatment without complications (≤ 30% residual stenosis) of significant stenosis (>50% stenosis) or occlusion of inflow tract proximal to the target treatment zone using percutaneous angioplasty or stent.

Standard Exclusion Criteria:

  1. Rutherford Clinical Category 0, 1, or 5 with ulcers extending proximal to the metatarsal head, Category 6, or physically unable to ambulate (e.g., bedridden).
  2. Subject has active infection requiring IV antibiotics in the target leg.
  3. Planned major amputation of the target leg (above the ankle or higher).
  4. Prior endovascular or surgical procedure on the index limb within the 30 days prior to enrollment (including thrombolysis).
  5. Previous use of other non-study IVL devices on the inflow tract proximal to the target treatment zone.
  6. Subject has a known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count less than 100,000/microliter, or international normalized ratio >1.5 at the time of enrollment.
  7. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
  8. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  9. Myocardial infarction within 60 days prior to enrollment.
  10. Stroke within 60 days prior to enrollment.
  11. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment.
  12. Subject has acute or chronic renal disease (serum creatinine of >2.5 mg/dL or eGFR \<30) or is on dialysis at the time of enrollment.
  13. Presence of venous insufficiency with history of venous ulceration in the target limb in the past year.
  14. Subject is pregnant or nursing.
  15. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
  16. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment.

Angiographic Exclusion Criteria:

  1. Target lesion(s) within native or synthetic vessel grafts.
  2. Any stent within the target lesion.
  3. Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon).
  4. Chronic total occlusions (CTOs) >100mm in length (ATK and BTK cohorts only).
  5. Use of: (1) CTO re-entry or (2) other non-study IVL devices on the target lesion.
  6. Lesions within 10mm of the ostium of the SFA.
  7. Lesion in contralateral limb requiring intervention within the next 30 days.
  8. Evidence of aneurysm or acute thrombus in target vessel.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    IVL Treatment Arm

    Device: IV-X Medical IVL System

Interventions

  • DeviceIV-X Medical IVL System

    The IV-X Medical Intravascular Lithotripsy (IVL) System (IV-X IVL System) is a balloon-based lithotripsy device designed to treat calcified peripheral artery lesions. The device employs sonic pressure waves to fracture the calcifications, restoring blood flow and improving vascular health.

06

What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint defined as the number of patients with a post-procedure residual diameter stenosis of <50% (after adjunctive therapy, if used), as assessed by quantitative angiography via core lab evaluation.

    Time frame: Day of Procedure

  2. Primary Safety Endpoint defined as freedom from a composite of the following new onset Major Adverse Events (MAEs)

    * Clinically driven target limb revascularization * Unplanned amputation of the target limb above the ankle * Device- or procedure-related post-operative death

    Time frame: Within 30 days post-procedure

Secondary outcomes

  1. Secondary endpoint of acute procedural success defined as number of patients with a post-procedure residual diameter stenosis of <50% (without additional PTA balloon insertion and treatment) as assessed by quantitative angiography via core lab evaluation

    Time frame: Day of Procedure

  2. Secondary Endpoint of Acute Procedural Success with Freedom from Procedural Adverse Events

    Defined as the number of patients with BOTH a post-procedure residual diameter stenosis of \<50% (after adjunctive therapy and/or stenting, if used) as assessed by Investigator via visual estimate and freedom from major procedural adverse events.

    Time frame: Day of Procedure

  3. Secondary Endpoint of Acute Procedural Success defined as number of patients with post-procedure residual diameter stenosis of ≤30% of the target lesion

    Defined as number of patients with post-procedure residual diameter stenosis of ≤30% of the target lesion (with or without adjunctive PTA or stent therapy) as assessed by quantitative angiography via core lab evaluation.

    Time frame: Day of Procedure

  4. Secondary endpoint of Acute Procedural Success defined as the number of procedures where IVL was successfully delivered in the desired location with 2 or fewer catheters.

    The ability of the IV-X IVL System to deliver IVL treatment to the desired location in the target vessel. Up to two (2) IVL catheters may be used to complete treatment in the target vessel.

    Time frame: Day of Procedure

  5. Freedom from Major Adverse Events (MAEs) within 6 Months of the Study Procedure

    Time frame: 6 Months

  6. Freedom from Non-Serious and Serious Adverse Events (SAEs)

    Time frame: 6 Months

  7. Freedom from Device- and Procedure-related Adverse Events (AEs)

    Time frame: 6 Months

  8. Freedom from Clinically Driven Target Lesion Revascularization at 30 days

    Time frame: 30 Days

  9. Freedom from Clinically Driven Target Lesion Revascularization at 6 months

    Time frame: 6 Months

  10. Freedom from Unplanned Major Amputation of the Target Limb (Above the Ankle)

    Time frame: 6 Months

  11. Change in Rutherford Clinical Category Score at 30 days, Compared to Baseline

    Time frame: 30 Days

  12. Change in Rutherford Clinical Category Score at 6 Months, Compared to Baseline

    Time frame: 6 Months

  13. Change in Quality of Life between Baseline and 30 Days measured using the VasQOL-6 survey

    The Vascular Quality of Life Questionnaire 6 (VasQOL-6) includes six items for patients to rank on a 4-point Likert scale, yielding a total score ranging from 6 to 24, where higher scores indicate better quality of life.

    Time frame: 30 Days

  14. Change in Quality of Life between Baseline and 30 Days measured using the EQ-5D-3L survey.

    The EQ-5D-3L (3-Level) survey evaluates five dimensions of patient quality of life (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The 3-levels for ranking are: no problems, some problems, and extreme problems. The ranking for each dimension can be used to evaluate a patient's current health state.

    Time frame: 30 days

  15. Change in Quality of Life between Baseline and 6 Months measured using the VasQOL-6 survey.

    The Vascular Quality of Life Questionnaire 6 (VasQOL-6) includes six items for patients to rank on a 4-point Likert scale, yielding a total score ranging from 6 to 24, where higher scores indicate better quality of life.

    Time frame: 6 Months

  16. Change in Quality of Life between Baseline and 6 Months measured using the EQ-5D-3L survey.

    The EQ-5D-3L (3-Level) survey evaluates five dimensions of patient quality of life (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The 3-levels for ranking are: no problems, some problems, and extreme problems. The ranking for each dimension can be used to evaluate a patient's current health state.

    Time frame: 6 Months

  17. Secondary Endpoint for Treatment Success defines as Number of patents with Target Lesion Patency

    Target Lesion Patency Defined as Freedom from \>50% Restenosis at 6 Months Post-procedure (Core Lab Assessed Duplex Ultrasound Peak Systolic Velocity Ration ≥2.4)

    Time frame: 6 Months

  18. Change in Ankle-Brachial Index (ABI) and/or Toe Brachial Index (TBI) of the Target Limb at 30 Days, Compared to Baseline

    Time frame: 30 Days

  19. Change in Ankle-Brachial Index (ABI) and/or Toe Brachial Index (TBI) of the Target Limb at 6 Months, Compared to Baseline

    Time frame: 6 Months

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Status
Withheld→Not yet recruiting
changed Oct 21, 2026
Start date
Set to Dec 2026
Oct 21, 2026
Primary completion
Set to Sep 30, 2027
Oct 21, 2026
Study completion
Set to Jan 30, 2028
Oct 21, 2026
Also revised
eligibility, interventions and sponsor
Show all 1 update
  1. Oct 21, 2026
    Withheld→Not yet recruiting
    Start date Set to Dec 2026
    Primary completion Set to Sep 30, 2027
    Study completion Set to Jan 30, 2028
    Eligibility Criteria revised
    Interventions Arms or interventions changed
    Sponsor [Redacted]→IVX Medical
    + 10 other changes: index terms, identifiers, registry dates, verification date, oversight details, description, conditions, design details, secondary outcomes and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07746362
Lead sponsor
IVX Medical
Responsible party
Sponsor
First posted
Aug 5, 2026
Start date
Dec 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Jan 30, 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

Laura Seiberlich, MS, MBA
Contact
lseiberlich@ivxmed.com
+1-651-204-0567

Oversight

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

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