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

This study has been terminated.
(Data was inconclusive)
Sponsor:
Information provided by (Responsible Party):
Vessix Vascular, Inc
ClinicalTrials.gov Identifier:
NCT00881257
First received: April 13, 2009
Last updated: June 19, 2013
Last verified: June 2013

April 13, 2009
June 19, 2013
August 2007
November 2009   (final data collection date for primary outcome measure)
Major Adverse Clinical Events Rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00881257 on ClinicalTrials.gov Archive Site
  • Binary Restenosis [ Time Frame: 30 days, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: 30 days, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Amputation Rate [ Time Frame: 30 days, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Technical Success [ Time Frame: Treatment ] [ Designated as safety issue: No ]
  • Serious Adverse Events rate, including Major Adverse Clinical Events [ Time Frame: 30 days, 3 months, 6 months, and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Vascular Disease
Device: GRST Peripheral Catheter System
Treatment to dilate stenoses and reduce plaque in treated vessels
Experimental: 1
GRST Peripheral Catheter System
Intervention: Device: GRST Peripheral Catheter System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
78
May 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00881257
DR0148
Yes
Vessix Vascular, Inc
Vessix Vascular, Inc
Not Provided
Principal Investigator: Hans Krankenberg, MD Hamburg University Cardiovascular Center
Vessix Vascular, Inc
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP