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

NCT ID: NCT00751283

Last Updated: 2013-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-05-31

Brief Summary

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.

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

GRST Peripheral Catheter System

Group Type: EXPERIMENTAL

GRST Peripheral Catheter System

Intervention Type: DEVICE

Treatment to dilate stenoses and reduce plaque in treated vessels

Interventions

GRST Peripheral Catheter System

Treatment to dilate stenoses and reduce plaque in treated vessels

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vessix Vascular, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Leipzig Herzzentrum

Countries

Argentina; Chile; Germany

Other Identifiers

DR0052

Identifier Type: -

Identifier Source: org_study_id