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Not yet recruiting NCT07575568

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

No phase Interventional Peripheral Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serranator Sonic Intravascular Lithotripsy (IVL) System.
Who it may be relevant to
Registry conditions: Peripheral Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Serranator Sonic Intravascular Lithotripsy (IVL) System
    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 outcome measures

  • Primary Safety: Major Adverse Events [Time frame: 30 Days]
  • Primary Effectiveness: Procedural Success [Time frame: Procedure]
Secondary outcome measures (9)
  • Freedom from Major Adverse Events at 6 months [Time frame: 6 months]
  • Freedom from Major Adverse Events at 12 months [Time frame: 12 months]
  • Procedural success of ≤30% residual stenosis of the target lesion [Time frame: Procedure]
  • Patency rates of target lesion by duplex ultrasound [Time frame: 30 Days, 6 Months, and 12 Months]
  • Freedom from clinically-driven target lesion revascularization [Time frame: 30 Days, 6 Months, and 12 Months]
  • Change in Ankle-Brachial Index/Toe-Brachial Index [Time frame: 30 Days, 6 Months, and 12 Months]
  • Change in Rutherford Category [Time frame: 30 Days, 6 Months, and 12 Months]
  • Change in Walking Impairment Questionnaire score [Time frame: 30 Days, 6 Months, and 12 Months]
  • Change in EuroQol-5D-3L [Time frame: 30 Days, 6 Months, and 12 Months]

Eligibility criteria

\*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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07575568 · CSP-1179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗