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Clinical Trials/NCT00751283
NCT00751283WithdrawnPhase 2

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

Vessix Vascular, Inc0 sitesStarted: August 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Primary Endpoint
Major adverse clinical events rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

GRST Peripheral Catheter System

Intervention: GRST Peripheral Catheter System (Device)

Outcomes

Primary Outcomes

Major adverse clinical events rate

Time Frame: Up to 30 days

Secondary Outcomes

  • Amputation rate(30 days, 3 months, 6 months)
  • Binary restenosis(30 days, 3 months, 6 months)
  • Target lesion revascularization(30 days, 3 months, 6 months)
  • Technical success(Treatment)
  • Serious adverse events rate, including major adverse clinical events(30 days, 3 months, 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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