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

NCT ID: NCT02400905

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-29
• Study Completion Date: 2019-12-03

Brief Summary

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.

Detailed Description

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BioMimics 3D Vascular Stent

Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System

Group Type: EXPERIMENTAL

BioMimics 3D Vascular Stent System

Intervention Type: DEVICE

Femoropopliteal stenting

Interventions

BioMimics 3D Vascular Stent System

Femoropopliteal stenting

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinLogix. LLC

INDUSTRY

Sponsor Role: collaborator

Yale Cardiovascular Research Group

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Veryan Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy M. Sullivan, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute / Abbott Northwestern Hospital

Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Herz-Zentrum University Hospital

Masato Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Toho University Ohashi Medical Center

Locations

Brookwood Medical Center

Birmingham, Alabama, United States

Cardiology Associates of Mobile

Mobile, Alabama, United States

Arizona Heart Hospital

Phoenix, Arizona, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Bradenton Cardiology Center

Bradenton, Florida, United States

MediQuest Research Group/ Munroe Regional Medical Center

Ocala, Florida, United States

Coastal Vascular

Pensacola, Florida, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Kings Daughters Medical Center

Ashland, Kentucky, United States

Endovascular Technologies / Grace Research

Bossier City, Louisiana, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Cardiovascular Institute of the South

Lafayette, Louisiana, United States

Michigan Outpatient Vascular Institute

Dearborn, Michigan, United States

St. John Hospital & Medical Center

Detroit, Michigan, United States

Michigan Vascular Center

Flint, Michigan, United States

Minneapolis Heart

Minneapolis, Minnesota, United States

Deborah Heart & Lung Center

Browns Mills, New Jersey, United States

NC Heart & Vascular Research

Raleigh, North Carolina, United States

WakeMed Research

Raleigh, North Carolina, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, United States

Berks Cardiologists

Wyomissing, Pennsylvania, United States

North Central Heart

Sioux Falls, South Dakota, United States

Kore Cardiovascular Research

Jackson, Tennessee, United States

Austin Heart Research

Austin, Texas, United States

Cardiovascular Specialist of TX / North Austin Medical Center

Austin, Texas, United States

Grace Research

Huntsville, Texas, United States

Mission Research Institute/Guadalupe Regional Medical Center

New Braunfels, Texas, United States

Cardiovascular Associates of East Texas

Tyler, Texas, United States

Karolinen-Hospital

Arnsberg, , Germany

Universitaets-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, , Germany

Diakonissenkrankenhaus Flensburg

Flensburg, , Germany

Westküstenklinikum Heide

Heide, , Germany

Universitätsklinikum Leipzig AoR Leipzig

Leipzig, , Germany

St. Bonifatius Hospital

Lingen, , Germany

Kansai Rosai Hospital

Hyōgo, , Japan

Kasukabe Chuo General Hospital

Kasukabe, , Japan

Kokura Memorial Hospital

Kitakyushu-shi, , Japan

Morinomiya Hospital

Osaka, , Japan

Omihachiman Community Medical Center

Shiga, , Japan

Toho University Ohashi Medical Center

Tokyo, , Japan

Countries

United States; Germany; Japan

References

Sullivan TM, Zeller T, Nakamura M, Gaines PA; MIMICS-2 Trial Investigators. Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial. J Endovasc Ther. 2021 Apr;28(2):236-245. doi: 10.1177/1526602820980419. Epub 2020 Dec 17.

Reference Type: DERIVED

PMID: 33331207 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CID-100

Identifier Type: -

Identifier Source: org_study_id