NCT00881257TerminatedPhase 2
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Vessix Vascular, Inc
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Major Adverse Clinical Events Rate
Study Overview
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 femoral artery (SFA) 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 of age.
- •Patient is Rutherford category 2-
- •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 Criteria
- •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.
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
- Binary Restenosis(30 days, 3 months, 6 months and 12 months)
- Target Lesion Revascularization(30 days, 3 months, 6 months and 12 months)
- Amputation Rate(30 days, 3 months, 6 months, and 12 months)
- Technical Success(Treatment)
- Serious Adverse Events rate, including Major Adverse Clinical Events(30 days, 3 months, 6 months, and 12 months)
Investigators
Study Sites (2)
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