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

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00881257
• Other study ID #: DR0148
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 13, 2009
• Last updated: June 19, 2013
• Start date: August 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2013
• Source: Vessix Vascular, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• GRST Peripheral Catheter System
Treatment to dilate stenoses and reduce plaque in treated vessels

Locations

Country	Name	City	State
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Hamburg University Cardiovascular Center	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Vessix Vascular, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Clinical Events Rate		Up to 30 days	Yes
Secondary	Binary Restenosis		30 days, 3 months, 6 months and 12 months	No
Secondary	Target Lesion Revascularization		30 days, 3 months, 6 months and 12 months	No
Secondary	Amputation Rate		30 days, 3 months, 6 months, and 12 months	No
Secondary	Technical Success		Treatment	No
Secondary	Serious Adverse Events rate, including Major Adverse Clinical Events		30 days, 3 months, 6 months, and 12 months	Yes