- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00881257
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
June 19, 2013 updated by: Vessix Vascular, Inc
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bad Krozingen, Germany, 79189
- Herz-Zentrum Bad Krozingen
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Hamburg, Germany, 22527
- Hamburg University Cardiovascular Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
GRST Peripheral Catheter System
|
Treatment to dilate stenoses and reduce plaque in treated vessels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major Adverse Clinical Events Rate
Time Frame: Up to 30 days
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Binary Restenosis
Time Frame: 30 days, 3 months, 6 months and 12 months
|
30 days, 3 months, 6 months and 12 months
|
Target Lesion Revascularization
Time Frame: 30 days, 3 months, 6 months and 12 months
|
30 days, 3 months, 6 months and 12 months
|
Amputation Rate
Time Frame: 30 days, 3 months, 6 months, and 12 months
|
30 days, 3 months, 6 months, and 12 months
|
Technical Success
Time Frame: Treatment
|
Treatment
|
Serious Adverse Events rate, including Major Adverse Clinical Events
Time Frame: 30 days, 3 months, 6 months, and 12 months
|
30 days, 3 months, 6 months, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hans Krankenberg, MD, Hamburg University Cardiovascular Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (ACTUAL)
November 1, 2009
Study Completion (ACTUAL)
May 1, 2010
Study Registration Dates
First Submitted
April 13, 2009
First Submitted That Met QC Criteria
April 14, 2009
First Posted (ESTIMATE)
April 15, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 20, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DR0148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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