Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: BioMimics 3D Vascular Stent System

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.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany
    • Karolinen-Hospital
  • Bad Krozingen, Germany
    • Universitaets-Herzzentrum Freiburg-Bad Krozingen
  • Flensburg, Germany
    • Diakonissenkrankenhaus Flensburg
  • Heide, Germany
    • Westküstenklinikum Heide
  • Leipzig, Germany
    • Universitätsklinikum Leipzig AoR Leipzig
  • Lingen, Germany
    • St. Bonifatius Hospital
• Japan
  • Hyogo, Japan
    • Kansai Rosai Hospital
  • Kasukabe, Japan
    • Kasukabe Chuo General Hospital
  • Kitakyushu-shi, Japan
    • Kokura Memorial Hospital
  • Osaka, Japan
    • Morinomiya Hospital
  • Shiga, Japan
    • Omihachiman Community Medical Center
  • Tokyo, Japan
    • Toho University Ohashi Medical Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Brookwood Medical Center
    • Mobile, Alabama, United States, 36532
      • Cardiology Associates of Mobile
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Heart Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
    • Ocala, Florida, United States, 34471
      • MediQuest Research Group/ Munroe Regional Medical Center
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular
  • Illinois
    • Peoria, Illinois, United States, 61637
      • OSF St. Francis Medical Center
    • Springfield, Illinois, United States, 62701
      • Prairie Education And Research Cooperative
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Kings Daughters Medical Center
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Endovascular Technologies / Grace Research
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
    • Lafayette, Louisiana, United States, 70503
      • Cardiovascular Institute of the South
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Michigan Outpatient Vascular Institute
    • Detroit, Michigan, United States, 48236
      • St. John Hospital & Medical Center
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart & Lung Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27067
      • NC Heart & Vascular Research
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Research
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Harrisburg, Pennsylvania, United States, 17043
      • Pinnacle Health Harrisburg
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Cardiologists
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57018
      • North Central Heart
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Kore Cardiovascular Research
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart Research
    • Austin, Texas, United States, 78758
      • Cardiovascular Specialist of TX / North Austin Medical Center
    • Huntsville, Texas, United States, 77340
      • Grace Research
    • New Braunfels, Texas, United States, 78130
      • Mission Research Institute/Guadalupe Regional Medical Center
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associates of East Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioMimics 3D Vascular Stent; Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System	Device: BioMimics 3D Vascular Stent System; Femoropopliteal stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety (Overall MAE Rate at 30 Days)	Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.	30 Days
Long Term Safety (Overall MAE Rate at Month 12)	Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.	12 months
Number of Participants With Serious Adverse Events	Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.	36 Months
Technical Success	Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure	Procedural (at end of index procedure)
Primary Stent Patency	Determined at Months-12 and 24 using values of: PSVR >2.0, >2.4; >2.5; and >3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals >50% diameter stenosis or where the subject undergoes clinically-driven TLR. Further analysis of the patency data purely using a reference PSVR of >2.4, >2.5 and >3.5 was not feasible from the data that was collected.	Months 12 & 24
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More	Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24. Categories 0 - Asymptomatic; - Mild claudication; - Moderate claudication; - Severe claudication; - Ischemic rest pain; - Minor tissue loss; - Major tissue loss	Baseline, Day 30, Months 12 & 24
Clinical Outcome (Six-Minute Walk Test)	Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).	Baseline, Day 30, Months 12 & 24
Functional Outcome (Ankle Brachial Index (ABI) Measurement)	Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.	Baseline, Day 30, Months 12 & 24
Change of Walking Impairment Questionnaire Score	Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24. The WIQ consists of 3 primary categories assessing walking distance, stair-climbing, and walking speed, as previously described. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none).	Baseline, Day 30, Months 12 & 24
Number of Participants With Freedom From Stent Fracture	Stent integrity measured as freedom from fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays taken with the leg in extension at 12, 24 and 36 Months.	Months 12, 24 & 36

Collaborators and Investigators

• Sponsor: Veryan Medical Ltd.
• Collaborators: Massachusetts General Hospital; ClinLogix. LLC; Yale Cardiovascular Research Group
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2015
• Primary Completion (Actual): November 3, 2017
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: PAD; PVD; SFA stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CID-100