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

Minnow Medical GRST Peripheral Catheter System First-in-Man Study Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

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.

Study Overview

• Status: Withdrawn
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: GRST Peripheral Catheter System

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; GRST Peripheral Catheter System	Device: GRST Peripheral Catheter System; Treatment to dilate stenoses and reduce plaque in treated vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse clinical events rate	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Binary restenosis	30 days, 3 months, 6 months
Target lesion revascularization	30 days, 3 months, 6 months
Amputation rate	30 days, 3 months, 6 months
Technical success	Treatment
Serious adverse events rate, including major adverse clinical events	30 days, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Vessix Vascular, Inc
• Investigators: Principal Investigator: Dierk Scheinert, MD, Universität Leipzig Herzzentrum

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 9, 2008
• First Submitted That Met QC Criteria: September 9, 2008
• First Posted (Estimate): September 11, 2008

Study Record Updates

• Last Update Posted (Estimate): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: DR0052