Serranator Recoil Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05161039
• Other study ID #: CSP-0485
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: July 2022

Study information

• Verified date: June 2022
• Source: Cagent Vascular LLC
• Contact: Robert Giasolli
• Phone: 610.688.2006
• Email: rgiasolli[@]cagentvascular.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Serranator
Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular
• POBA
Plain balloon angioplasty device

Locations

Country	Name	City	State
Germany	Klinik für Angiologie, Klinikum Hochsauerland GmbH	Arnsberg
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Cagent Vascular LLC

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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