Serrantor OCT Study

Part of paid clinical trials in New York, New York.

Sponsor
Cagent Vascular LLC
Study ID
NCT06434194
Status
Recruiting
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Conditions

  • Critical Limb Ischemia

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serranator PTA Serration Catheter — DEVICE
    The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
  • PTA (Standard of Care) — DRUG
    A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.

Study Details

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

Key Dates

Start date
Oct 31, 2024
Status verified
May 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Serrantor
    Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
  • Active Comparator: PTA
    Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.

Primary Outcome Measure

Residual Lumen Volume Stenosis [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032
K Dalton
Weill Cornell MedicalNew YorkNew York10065
R Chu

Find similar trials in New York, NY

By research site
Columbia University· New York, NYWeill Cornell Medical· New York, NY

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