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

NCT00881257 | Terminated Phase 2 DMC

• 1 other identifier: DR0148
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Vascular Disease

Keywords

Peripheral Vascular Disease; Peripheral Artery Disease; Radiofrequency

Outcome Measures

Primary Outcomes (1)

• Major Adverse Clinical Events Rate

  Up to 30 days

Secondary Outcomes (5)

• Binary Restenosis

  30 days, 3 months, 6 months and 12 months

• Target Lesion Revascularization

  30 days, 3 months, 6 months and 12 months

• Amputation Rate

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

• Technical Success

  Treatment

• Serious Adverse Events rate, including Major Adverse Clinical Events

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

Study Arms (1)

1

EXPERIMENTAL

GRST Peripheral Catheter System

Device: GRST Peripheral Catheter System

Interventions

GRST Peripheral Catheter System DEVICE

Treatment to dilate stenoses and reduce plaque in treated vessels

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vessix Vascular, Inc: lead

Study Sites (2)

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Hans Krankenberg, MD

  Hamburg University Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: August 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: May 1, 2010
• Last Updated: June 20, 2013

Record last verified: 2013-06

Locations

DE (2)