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

This study has been withdrawn prior to enrollment.
(Data was inconclusive)
Sponsor:
Information provided by (Responsible Party):
Vessix Vascular, Inc
ClinicalTrials.gov Identifier:
NCT00751283
First received: September 9, 2008
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Disease
Device: GRST Peripheral Catheter System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minnow Medical GRST Peripheral Catheter System First-in-Man Study Radiofrequency for the Treatment of Peripheral Vascular Occlusive Disease of the Lower Extremities

Resource links provided by NLM:


Further study details as provided by Vessix Vascular, Inc:

Primary Outcome Measures:
  • Major adverse clinical events rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Binary restenosis [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Amputation rate [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Technical success [ Time Frame: Treatment ] [ Designated as safety issue: No ]
  • Serious adverse events rate, including major adverse clinical events [ Time Frame: 30 days, 3 months, 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2007
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
GRST Peripheral Catheter System
Device: GRST Peripheral Catheter System
Treatment to dilate stenoses and reduce plaque in treated vessels

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751283

Sponsors and Collaborators
Vessix Vascular, Inc
Investigators
Principal Investigator: Dierk Scheinert, MD Universität Leipzig Herzzentrum
  More Information

No publications provided

Responsible Party: Vessix Vascular, Inc
ClinicalTrials.gov Identifier: NCT00751283     History of Changes
Other Study ID Numbers: DR0052
Study First Received: September 9, 2008
Last Updated: August 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 15, 2014