Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - 85
Updated:1/20/2019
Start Date:June 29, 2015
End Date:December 2019

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MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease

To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA
Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of
symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm,
multicenter clinical trial.

The BioMimics 3D stent is intended to improve luminal diameter in the treatment of
symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with
reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic
atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility
criteria may be considered for enrollment.

Inclusion Criteria:

- Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring
intervention to relieve de novo obstruction or occlusion of the native femoropopliteal
artery.

- PAD classified as Rutherford clinical category 2, 3 or 4.

- Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target
limb) or angiographic or DUS evidence of >/= 60%.

- Single or multiple stenotic or occlusive lesions within the native femoropopliteal
artery ("target lesions") that can be crossed with a guidewire and fully dilated.

- Single or multiple target lesions must be covered by a single stent or two overlapping
stents.

- Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep
femoral artery and at least 3 cm above the bottom of the femur.

- Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm.

- Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with
≥60% diameter stenosis by operator's visual estimate.

- Patent popliteal artery (no stenosis ≥50%) distal to the treated segment.

- At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle.

Exclusion Criteria:

- Iliac stent in target limb that has required re-intervention within 12 months prior to
index.

- Target vessel that has been treated with bypass surgery.

- PAD classified as Rutherford clinical category 0, 1, 5 or 6.

- Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count
less than 100,000/microliter or INR >1.8.

- Stroke diagnosis within 3 months prior to enrollment.

- History of unstable angina or myocardial infarction within 60 days prior to
enrollment.

- Thrombolysis within 72 hours prior to the index procedure.

- Acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL
or >220 umol/L), or on peritoneal or hemodialysis.

- Significant disease or obstruction (≥50%) of the inflow tract that has not been
successfully treated at the time of the index procedure (success measured as ≤30%
residual stenosis, without complication).

- No patent (≥50% stenosis) outflow vessel providing run-off to the ankle.

- Target lesion(s) requires percutaneous interventional treatment, beyond standard
balloon angioplasty alone, prior to placement of the study stent.
We found this trial at
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Flint, Michigan 98507
Principal Investigator: Robert Molnar, MD
Phone: 810-600-2009
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5 Stolte Ley
Arnsberg, 59759
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Ashland, Kentucky 41101
Principal Investigator: Omran Abul-Khoudoud, MD
Phone: 606-408-1724
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Austin, Texas 78756
Principal Investigator: Roger Gammon, MD
Phone: 512-206-3614
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Austin, Texas 78758
Principal Investigator: Manish Chauhan, MD
Phone: 512-334-8973
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Birmingham, Alabama 35243
Principal Investigator: Gary Roubin, MD
Phone: 205-795-5197
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Bossier City, Louisiana 71111
Principal Investigator: William B Eaves, MD
Phone: 318-638-7309
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Bradenton, Florida 34205
Principal Investigator: Srinivas Iyengar, MD
Phone: 941-748-2277
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Browns Mills, New Jersey 08015
Principal Investigator: Vincent Varghese, DO
Phone: 609-893-6611
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: Michael Jolly, MD
Phone: 614-556-1277
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Dearborn, Michigan 48126
Principal Investigator: Elias Kassab, MD
Phone: 313-505-1296
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Detroit, Michigan 48236
Principal Investigator: Thomas Davis, MD
Phone: 313-342-7536
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Doylestown, Pennsylvania 18901
Principal Investigator: Joseph McGarvey, MD
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Harrisburg, Pennsylvania 17104
Principal Investigator: William Bachinsky, MD
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Houma, Louisiana 70360
Principal Investigator: Craig Walker, MD
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Huntsville, Texas 77340
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Jackson, Tennessee 38305
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Lafayette, Louisiana 70506
Principal Investigator: Ankur Lodha, MD
Phone: 337-289-8429
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Minneapolis, Minnesota 55407
Principal Investigator: Elliot Stephenson, MD
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Mobile, Alabama 36608
Principal Investigator: Frank Bunch, MD
Phone: 251-990-1936
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New Braunfels, Texas 78130
Principal Investigator: Rahul Bose, MD
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Robert Attaran, MD
Phone: 203-785-5929
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Ocala, Florida 34471
Principal Investigator: Robert Feldman, MD
Phone: 352-351-7337
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Pensacola, Florida 32501
Principal Investigator: Huey McDaniel, MD
Phone: 850-479-1805
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530 NE Glen Oak Ave
Peoria, Illinois 61637
(309) 655-2000
Principal Investigator: James Swischuk, MD
Phone: 309-624-8762
OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
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Phoenix, Arizona 85006
Principal Investigator: Venkatesh Ramaiah, MD
Phone: 602-604-5021
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Raleigh, North Carolina 27610
Principal Investigator: Islam Othman, MD
Phone: 919-350-8317
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Raleigh, North Carolina 27610
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3100 Duraleigh Road
Raleigh, North Carolina 27610
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Sioux Falls, South Dakota 57018
Principal Investigator: Michael Bacharach, MD
Phone: 605-977-5336
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Springfield, Illinois 62701
Principal Investigator: Jeffrey Goldstein, MD
Phone: 217-492-9100
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Wyomissing, Pennsylvania 19610
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Phone: 610-685-4843
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