Serranator Recoil Study

NCT05161039 | Unknown FDA Device

• 1 other identifier: CSP-0485
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Serranator

OTHER

Device: Serranator

POBA

OTHER

Device: POBA

Interventions

Serranator DEVICE

Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular

Serranator

POBA DEVICE

Plain balloon angioplasty device

POBA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of \>18 years old.
• Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
• 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.
• Subject has Rutherford Clinical Category 3, 4, 5, or 6.
• Target lesion(s) has stenosis \>70% by visual assessment;
• De-novo, or non-stented re-stenotic lesions;
• Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
• Target lesions involve infrapopliteal tibial arteries including pedal;
• A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;
• 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.

You may not qualify if:

• Evidence of aneurysm or acute thrombus in the target vessel.
• Subject has an allergy to contrast medium that cannot be pretreated.
• Subject is pregnant or breastfeeding.
• Acute Total Occlusions; evidence of acute thrombus formation by angiography.
• In-stent restenotic lesions.
• Inability to cross the lesion with the assigned study device.
• Treatment of target lesion with atherectomy.

Sponsors & Collaborators

• Cagent Vascular LLC: lead

Study Sites (2)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

Klinik für Angiologie, Klinikum Hochsauerland GmbH

Arnsberg, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Robert Giasolli

CONTACT

610.688.2006; rgiasolli@cagentvascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 16, 2021
• Study Start: November 15, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

US (1); DE (1)