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NCT Number: NCT07575568

Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

*Inclusion Criteria for Cohort A: ATK arm of the study:

Clinical:

  • Subject is ≥ 18 years of age
  • Target limb is Rutherford Clinical Category 2, 3 or 4
  • Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb

Angiographic:

  • Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery
  • Reference vessel diameter (RVD) between 4.0 and 8.0mm
  • Target lesion must have a diameter stenosis of ≥70%
  • Lesion calcification is at least moderate
  • Total planned target lesion length must be ≤150mm
  • Chronic total occlusion lesion length is ≤100mm
  • Subject has at least one patent tibial vessel on the target limb with runoff to the foot
  • Exclusion Criteria for Cohort A: ATK arm of the study:

Clinical:

  • Rutherford Clinical Categories 0, 1, 5 and 6
  • Subject with known pregnancy or is nursing
  • Subject has acute or chronic renal disease, defined as serum creatinine of >2.5 mg/dL or >220 µmol/L or on dialysis

Angiographic:

  • Target lesions >150mm by visual estimation
  • Chronic total occlusions > 100mm by visual estimation
  • No or mild calcium present in the target lesion
  • Inclusion Criteria for Cohort B: BTK arm of the study:

Clinical:

  • Age of subject is ≥18
  • Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)

Angiographic:

  • Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels
  • Target vessel reference diameter is between 2.5mm and 4.0 mm
  • Target lesion with diameter stenosis ≥50%
  • Target lesion is ≤150mm in length
  • Subject has at least one patent tibial vessel (>50%) with run-off to the foot.
  • Calcification is at least moderate
  • Exclusion Criteria for Cohort B: BTK arm of the study:

Clinical:

  • Rutherford Clinical Category 0,1 or 6
  • Gangrene of the lower extremity
  • Patient is pregnant or nursing

Angiographic:

  • Target lesion is within only lower extremity vessel with < 50% stenosis
  • Target lesion length exceeds 150mm
  • Patient has chronic total occlusion of target lesion

Treatment and study plan

Serranator Sonic Intravascular Lithotripsy (IVL) System

Device

Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.

Primary outcomes

  1. Primary Safety: Major Adverse Events

    Time frame: 30 Days

    Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of:

    • All cardiovascular death
    • Major amputation
    • Clinically-driven target lesion revascularization (CD-TLR)

  2. Primary Effectiveness: Procedural Success

    Time frame: Procedure

    Procedural Success, defined as:

    <50% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core-lab assessment

Secondary outcomes

  1. Freedom from Major Adverse Events at 6 months

    Time frame: 6 months

    Freedom from Major Adverse Events, defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization

  2. Freedom from Major Adverse Events at 12 months

    Time frame: 12 months

    Freedom from Major Adverse Events defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization.

  3. Procedural success of ≤30% residual stenosis of the target lesion

    Time frame: Procedure

    Procedural success of ≤30% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core lab assessment

  4. Patency rates of target lesion by duplex ultrasound

    Time frame: 30 Days, 6 Months, and 12 Months

    Patency rates at 30 days, 6 months, and 12 months of target lesion by duplex ultrasound. Target vessel patency by duplex ultrasound, defined as freedom from > 50% restenosis, as assessed by duplex ultrasound peak systolic velocity ratio of ≥2.5

  5. Freedom from clinically-driven target lesion revascularization

    Time frame: 30 Days, 6 Months, and 12 Months

    Freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days, 6 months, and 12 months

  6. Change in Ankle-Brachial Index/Toe-Brachial Index

    Time frame: 30 Days, 6 Months, and 12 Months

    Change in Ankle-Brachial Index/Toe-Brachial Index (TBI) at 30 days, 6 months, and 12 months, as compared to baseline

  7. Change in Rutherford Category

    Time frame: 30 Days, 6 Months, and 12 Months

    Change in Rutherford Category at 30 days, 6 months and 12 months, as compared to baseline

  8. Change in Walking Impairment Questionnaire score

    Time frame: 30 Days, 6 Months, and 12 Months

    Change in Walking Impairment Questionnaire (WIQ) score at 30 days, 6 months and 12 months, as compared to baseline

  9. Change in EuroQol-5D-3L

    Time frame: 30 Days, 6 Months, and 12 Months

    Change in EuroQol-5D-3L (EQ-5D-3L) at 30 days, 6 months and 12 months, as compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis Shewfelt

CONTACT

[email protected]

650-208-6743

Jennifer Meyers Sullivan

CONTACT

[email protected]

219-730-9402

Sponsors and collaborators

Lead sponsor

Cagent Vascular LLC

Industry

Collaborators

  • Australian Healthcare Solutions
  • Clinical Accelerator
  • Yale Cardiovascular Research Group

Registry information

Official study title

REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

Acronym: REMODEL I

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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