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Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System

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ClinicalTrials.gov Identifier: NCT00881257
Recruitment Status : Terminated (Data was inconclusive)
First Posted : April 15, 2009
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Vessix Vascular, Inc

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: GRST Peripheral Catheter System Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
Study Start Date : August 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
GRST Peripheral Catheter System
Device: GRST Peripheral Catheter System
Treatment to dilate stenoses and reduce plaque in treated vessels




Primary Outcome Measures :
  1. Major Adverse Clinical Events Rate [ Time Frame: Up to 30 days ]

Secondary Outcome Measures :
  1. Binary Restenosis [ Time Frame: 30 days, 3 months, 6 months and 12 months ]
  2. Target Lesion Revascularization [ Time Frame: 30 days, 3 months, 6 months and 12 months ]
  3. Amputation Rate [ Time Frame: 30 days, 3 months, 6 months, and 12 months ]
  4. Technical Success [ Time Frame: Treatment ]
  5. Serious Adverse Events rate, including Major Adverse Clinical Events [ Time Frame: 30 days, 3 months, 6 months, and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881257


Locations
Germany
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Hamburg University Cardiovascular Center
Hamburg, Germany, 22527
Sponsors and Collaborators
Vessix Vascular, Inc
Investigators
Principal Investigator: Hans Krankenberg, MD Hamburg University Cardiovascular Center

Responsible Party: Vessix Vascular, Inc
ClinicalTrials.gov Identifier: NCT00881257     History of Changes
Other Study ID Numbers: DR0148
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Vessix Vascular, Inc:
Peripheral Vascular Disease
Peripheral Artery Disease
Radiofrequency

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases