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

NCT00751283 | Withdrawn Phase 2 DMC

• 1 other identifier: DR0052
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Major adverse clinical events rate

  Up to 30 days

Secondary Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

GRST Peripheral Catheter System

Device: GRST Peripheral Catheter System

Interventions

GRST Peripheral Catheter System DEVICE

Treatment to dilate stenoses and reduce plaque in treated vessels

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vessix Vascular, Inc: lead

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dierk Scheinert, MD

  Universität Leipzig Herzzentrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 11, 2008
• Study Start: August 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: May 1, 2011
• Last Updated: August 14, 2013

Record last verified: 2013-08