Clinical trial NCT00881257: Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
Official title: Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Peripheral Vascular Disease
Keywords: Peripheral Vascular Disease
Peripheral Artery Disease
Radiofrequency
Lead sponsor: Vessix Vascular, Inc
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥18 of age.
2. Patient is Rutherford category 2-4.
3. De novo single lesion with a diameter stenosis (%DS) of ≥50%
4. Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of \<99%.
5. Target lesion stenosis has a length of ≤100 mm based on visual assessment.
6. Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment.
7. Angiographic evidence of distal runoff defined as minimum one patent tibial artery with a straight flow to the foot.
8. Patient is willing and able to provide written informed consent prior to any study specific procedure.
9. Patient is willing and able to comply with specified follow-up evaluations at the specified times.

Exclusion Criteria:

1. Prior PTA in the intended target lesion including 10 mm proximal or distal from the intended treatment area.
2. Evidence of thrombus in the target vessel.
3. Prior ipsilateral or contralateral lower limb arterial bypass.
4. Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure.
5. Target lesion is severely calcified.
6. Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated).
7. Any planned surgery within 30 days of the study procedure.
8. Renal failure (serum creatinine \> 2.0 mg/dL).
9. Female with childbearing potential without a negative pregnancy test.
10. Patient has had an organ transplant.
11. 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.
12. In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.

Primary outcomes:
measure: Major Adverse Clinical Events Rate
timeFrame: Up to 30 days
Secondary outcomes:
measure: Binary Restenosis
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Target Lesion Revascularization
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Amputation Rate
timeFrame: 30 days, 3 months, 6 months, and 12 months
measure: Technical Success
timeFrame: Treatment
measure: Serious Adverse Events rate, including Major Adverse Clinical Events
timeFrame: 30 days, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Hamburg
country: Germany
facility: Hamburg University Cardiovascular Center
Study officials:
affiliation: Hamburg University Cardiovascular Center
name: Hans Krankenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: