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

Primary Purpose

Peripheral Vascular Disease

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

GRST Peripheral Catheter System

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Peripheral Vascular Disease, Peripheral Artery Disease, Radiofrequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Herz-Zentrum Bad Krozingen
Hamburg University Cardiovascular Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

GRST Peripheral Catheter System

Outcomes

Primary Outcome Measures

Major Adverse Clinical Events Rate

Secondary Outcome Measures

Binary Restenosis

Target Lesion Revascularization

Amputation Rate

Technical Success

Serious Adverse Events rate, including Major Adverse Clinical Events

Full Information

NCT ID

NCT00881257

First Posted

April 13, 2009

Last Updated

June 19, 2013

Sponsor

Vessix Vascular, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00881257

Brief Title

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

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Terminated

Why Stopped

Data was inconclusive

Study Start Date

August 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vessix Vascular, Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease

Keywords

Peripheral Vascular Disease, Peripheral Artery Disease, Radiofrequency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

GRST Peripheral Catheter System

Intervention Type

Device

Intervention Name(s)

GRST Peripheral Catheter System

Intervention Description

Treatment to dilate stenoses and reduce plaque in treated vessels

Primary Outcome Measure Information:

Title

Major Adverse Clinical Events Rate

Time Frame

Up to 30 days

Secondary Outcome Measure Information:

Title

Binary Restenosis

Time Frame

30 days, 3 months, 6 months and 12 months

Title

Target Lesion Revascularization

Time Frame

30 days, 3 months, 6 months and 12 months

Title

Amputation Rate

Time Frame

30 days, 3 months, 6 months, and 12 months

Title

Technical Success

Time Frame

Treatment

Title

Serious Adverse Events rate, including Major Adverse Clinical Events

Time Frame

30 days, 3 months, 6 months, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Krankenberg, MD

Organizational Affiliation

Hamburg University Cardiovascular Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herz-Zentrum Bad Krozingen

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Hamburg University Cardiovascular Center

City

Hamburg

ZIP/Postal Code

22527

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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