Serranator Recoil Study

Recoil Feasibility Study for the Treatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Comparing Serration Angioplasty (Serranator® Device) vs. Plain Balloon Angioplasty (POBA)

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: Serranator; Device: POBA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Giasolli; Phone Number: 610.688.2006; Email: rgiasolli@cagentvascular.com

Study Locations

• Germany
  • Arnsberg, Germany
    • Recruiting
    • Klinik für Angiologie, Klinikum Hochsauerland GmbH
    • Contact: Stefan Stahlhoff, MD
• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Venita Chandra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Angiographic Inclusion Criteria:

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.

Angiographic Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Serranator	Device: Serranator; Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular
Other: POBA	Device: POBA; Plain balloon angioplasty device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of post treatment recoil	Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty.	15 minutes post procedure

Collaborators and Investigators

• Sponsor: Cagent Vascular LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CSP-0485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes