Serrantor OCT Study
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)
1 other identifier
interventional
60
1 country
2
Brief Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMay 18, 2025
May 1, 2025
7 months
May 3, 2024
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
OCT Residual Diameter Stenosis
Baseline
Angiography Residual Diameter Stenosis
Baseline
Dissection Pattern
Baseline
Correlation of Luminal Gain and Plaque Modification
Baseline
Rate of Optimal PTA
Baseline
- +1 more secondary outcomes
Study Arms (2)
Serrantor
ACTIVE COMPARATORSubjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
PTA
ACTIVE COMPARATORSubjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.
Interventions
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Columbia University
New York, New York, 10032, United States
Weill Cornell Medical
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2024
First Posted
May 30, 2024
Study Start
October 31, 2024
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share