Serrantor OCT Study

Critical Limb Ischemia Clinical Trial

Official title:

Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434194
• Other study ID #: CSP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Cagent Vascular LLC
• Contact: Feeny
• Phone: 4197878496
• Email: kjclinconsulting[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Rutherford clinical category 4-6 of the target limb

• Age of subjects is >18 years old

• Patients has given informed consent to participate in this study

Exclusion Criteria:

• De novo or restenotic (without prior stent) stenosis (=70%) or occlusion

• Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.

• Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.

• Lesion length less than 220 mm

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia

Intervention

Device:
• Serranator PTA Serration Catheter
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.

Drug:
• PTA (Standard of Care)
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cagent Vascular LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Lumen Volume Stenosis	Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.	Baseline
Secondary	OCT Residual Diameter Stenosis	Residual stenosis as measured by OCT	Baseline
Secondary	Angiography Residual Diameter Stenosis	Residual stenosis as measured by angiography	Baseline
Secondary	Dissection Pattern	The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration.	Baseline
Secondary	Correlation of Luminal Gain and Plaque Modification	The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab.	Baseline
Secondary	Rate of Optimal PTA	Rate of procedures that achieve optimal PTA (<30% diameter stenosis without flow-limiting dissection measured by angiography)	Baseline
Secondary	Bail-out Stenting	Rate of bail-out stenting	Baseline