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

This study has been withdrawn prior to enrollment.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

Further study details as provided by Vessix Vascular, Inc:

Primary Outcome Measures:
  • Major adverse clinical events rate [ Time Frame: Up to 30 days ]

Secondary Outcome Measures:
  • Binary restenosis [ Time Frame: 30 days, 3 months, 6 months ]
  • Target lesion revascularization [ Time Frame: 30 days, 3 months, 6 months ]
  • Amputation rate [ Time Frame: 30 days, 3 months, 6 months ]
  • Technical success [ Time Frame: Treatment ]
  • Serious adverse events rate, including major adverse clinical events [ Time Frame: 30 days, 3 months, 6 months ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00751283

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

Responsible Party: Vessix Vascular, Inc Identifier: NCT00751283     History of Changes
Other Study ID Numbers: DR0052
Study First Received: September 9, 2008
Last Updated: August 12, 2013

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases processed this record on May 25, 2017