Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

Vessix Vascular

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Peripheral Vascular Disease

Treatments

Device: GRST Peripheral Catheter System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00751283

DR0052

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the Minnow Medical GRST Peripheral Catheter System in the treatment of new lesions in the superficial femoral artery or the popliteal artery.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is ≥18 years of age
Patient is Rutherford category 2-4
De novo lesion in the SFA or popliteal artery with a diameter stenosis ≥50%
Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of <99%
Target lesion stenosis has a length of ≤100 mm based on visual assessment
Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment
Angiographic evidence of distal runoff defined as minimum one (1) patent tibial artery with a straight flow to the foot
Patient is willing and able to provide written informed consent prior to any study specific procedure
Patient is willing and able to comply with specified follow-up evaluations at the specified times

Exclusion criteria

Any prior intervention in the intended target lesion including 10 mm proximal or distal from the intended treatment area
Evidence of thrombus in the target vessel
Prior ipsilateral or contralateral lower limb arterial bypass
Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure
Target lesion is severely calcified
Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated).
Any planned surgery within 30 days of the study procedure.
Renal failure (serum creatinine > 2.0 mg/dL)
Female with childbearing potential without a negative pregnancy test
Patient has had an organ transplant
Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study
In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study