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

NCT02400905 | Completed Results DMC

• 1 other identifier: CID-100
• Study Type: interventional
• Target: 271
• Locations: 3 countries
• Sites: 43

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.

Conditions

Peripheral Arterial Disease

Keywords

PAD; PVD; SFA stent

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)

  Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.

  30 days

• Primary Effectiveness Endpoint (Primary Stent Patency Rate)

  The primary effectiveness endpoint of the MIMICS-2 Study was defined as the primary stent patency rate at 12 months. Patency was defined as no significant reduction in luminal diameter (\< 50% diameter stenosis) since the index procedure. Loss of patency was determined by an independent core laboratory when the peak systolic velocity ratio (PSVR) exceeds 2.0, or where angiography revealed \> 50% diameter stenosis, or where the subject had a CDTLR.

  12 months

Secondary Outcomes (10)

• Secondary Safety (Overall MAE Rate at 30 Days)

  30 Days

• Long Term Safety (Overall MAE Rate at Month 12)

  12 months

• Number of Participants With Serious Adverse Events

  36 Months

• Technical Success

  Procedural (at end of index procedure)

• Primary Stent Patency

  Months 12 & 24

Study Arms (1)

BioMimics 3D Vascular Stent

EXPERIMENTAL

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

Device: BioMimics 3D Vascular Stent System

Interventions

BioMimics 3D Vascular Stent System DEVICE

Femoropopliteal stenting

BioMimics 3D Vascular Stent

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Veryan Medical Ltd.: lead
• ClinLogix. LLC: collaborator
• Yale Cardiovascular Research Group: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (43)

Brookwood Medical Center

Birmingham, Alabama, 35243, United States

Location

Cardiology Associates of Mobile

Mobile, Alabama, 36532, United States

Location

Arizona Heart Hospital

Phoenix, Arizona, 85006, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

MediQuest Research Group/ Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Coastal Vascular

Pensacola, Florida, 32504, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Kings Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Endovascular Technologies / Grace Research

Bossier City, Louisiana, 71111, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Cardiovascular Institute of the South

Lafayette, Louisiana, 70503, United States

Location

Michigan Outpatient Vascular Institute

Dearborn, Michigan, 48126, United States

Location

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

Minneapolis Heart

Minneapolis, Minnesota, 55407, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27067, United States

Location

WakeMed Research

Raleigh, North Carolina, 27610, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, 17043, United States

Location

Berks Cardiologists

Wyomissing, Pennsylvania, 19610, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57018, United States

Location

Kore Cardiovascular Research

Jackson, Tennessee, 38305, United States

Location

Austin Heart Research

Austin, Texas, 78756, United States

Location

Cardiovascular Specialist of TX / North Austin Medical Center

Austin, Texas, 78758, United States

Location

Grace Research

Huntsville, Texas, 77340, United States

Location

Mission Research Institute/Guadalupe Regional Medical Center

New Braunfels, Texas, 78130, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Karolinen-Hospital

Arnsberg, Germany

Location

Universitaets-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany

Location

Diakonissenkrankenhaus Flensburg

Flensburg, Germany

Location

Westküstenklinikum Heide

Heide, Germany

Location

Universitätsklinikum Leipzig AoR Leipzig

Leipzig, Germany

Location

St. Bonifatius Hospital

Lingen, Germany

Location

Kansai Rosai Hospital

Hyōgo, Japan

Location

Kasukabe Chuo General Hospital

Kasukabe, Japan

Location

Kokura Memorial Hospital

Kitakyushu-shi, Japan

Location

Morinomiya Hospital

Osaka, Japan

Location

Omihachiman Community Medical Center

Shiga, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 33331207 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nick Yeo
• Organization: Veryan Medical

nick.yeo@veryanmed.com

+44 1403 258984

Study Officials

• Timothy M. Sullivan, MD

  Minneapolis Heart Institute / Abbott Northwestern Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Zeller, MD

  Herz-Zentrum University Hospital

  PRINCIPAL INVESTIGATOR

• Masato Nakamura, MD

  Toho University Ohashi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 27, 2015
• Study Start: June 29, 2015
• Primary Completion: November 3, 2017
• Study Completion: December 3, 2019
• Last Updated: June 4, 2021
• Results First Posted: January 18, 2019

Record last verified: 2021-05

Locations

JP (6); US (31); DE (6)