Serranator Recoil Study

NCT ID: NCT05161039

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-07-31

Brief Summary

The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.

Detailed Description

Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Serranator

Group Type: OTHER

Serranator

Intervention Type: DEVICE

Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular

POBA

Group Type: OTHER

POBA

Intervention Type: DEVICE

Plain balloon angioplasty device

Interventions

Serranator

Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular

Intervention Type: DEVICE

POBA

Plain balloon angioplasty device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female of >18 years old.

2. Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.

3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.

4. Subject has Rutherford Clinical Category 3, 4, 5, or 6.

1. Target lesion(s) has stenosis >70% by visual assessment;

2. De-novo, or non-stented re-stenotic lesions;

3. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;

4. Target lesions involve infrapopliteal tibial arteries including pedal;

5. A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;

6. If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.

Exclusion Criteria

1. Evidence of aneurysm or acute thrombus in the target vessel.

2. Subject has an allergy to contrast medium that cannot be pretreated.

3. Subject is pregnant or breastfeeding.

1. Acute Total Occlusions; evidence of acute thrombus formation by angiography.

2. In-stent restenotic lesions.

3. Inability to cross the lesion with the assigned study device.

4. Treatment of target lesion with atherectomy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cagent Vascular LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Klinik für Angiologie, Klinikum Hochsauerland GmbH

Arnsberg, , Germany

Site Status: RECRUITING

Countries

United States; Germany

Central Contacts

Robert Giasolli

Role: CONTACT

rgiasolli@cagentvascular.com

610.688.2006

Facility Contacts

Venita Chandra, MD

Role: primary

Stefan Stahlhoff, MD

Role: primary

Other Identifiers

CSP-0485

Identifier Type: -

Identifier Source: org_study_id