Status:
TERMINATED
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
Lead Sponsor:
Vessix Vascular, Inc
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this clinical investigation is to evaluate the safety and efficacy of the Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the superficial femora...
Eligibility Criteria
Inclusion
- Patient is ≥18 of age.
- Patient is Rutherford category 2-4.
- De novo single lesion with a diameter stenosis (%DS) of ≥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 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
- Prior PTA 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00881257
Start Date
August 1 2007
End Date
May 1 2010
Last Update
June 20 2013
Active Locations (2)
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1
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
2
Hamburg University Cardiovascular Center
Hamburg, Germany, 22527