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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BioMimics 3D Vascular Stent System
Sponsored by
Veryan Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring PAD, PVD, SFA stent

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brookwood Medical Center
  • Cardiology Associates of Mobile
  • Arizona Heart Hospital
  • Yale New Haven Hospital
  • Bradenton Cardiology Center
  • MediQuest Research Group/ Munroe Regional Medical Center
  • Coastal Vascular
  • OSF St. Francis Medical Center
  • Prairie Education and Research Cooperative
  • Kings Daughters Medical Center
  • Endovascular Technologies / Grace Research
  • Cardiovascular Institute of the South
  • Cardiovascular Institute of the South
  • Michigan Outpatient Vascular Institute
  • St. John Hospital & Medical Center
  • Michigan Vascular Center
  • Minneapolis Heart
  • Deborah Heart & Lung Center
  • NC Heart & Vascular Research
  • WakeMed Research
  • Riverside Methodist Hospital
  • Doylestown Hospital
  • Pinnacle Health Harrisburg
  • Berks Cardiologists
  • North Central Heart
  • Kore Cardiovascular Research
  • Austin Heart Research
  • Cardiovascular Specialist of TX / North Austin Medical Center
  • Grace Research
  • Mission Research Institute/Guadalupe Regional Medical Center
  • Cardiovascular Associates of East Texas
  • Karolinen-Hospital
  • Universitaets-Herzzentrum Freiburg-Bad Krozingen
  • Diakonissenkrankenhaus Flensburg
  • Westküstenklinikum Heide
  • Universitätsklinikum Leipzig AoR Leipzig
  • St. Bonifatius Hospital
  • Kansai Rosai Hospital
  • Kasukabe Chuo General Hospital
  • Kokura Memorial Hospital
  • Morinomiya Hospital
  • Omihachiman Community Medical Center
  • Toho University Ohashi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BioMimics 3D Vascular Stent

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
Technical Success
Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at 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.
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
Clinical Outcome (Six-Minute Walk Test)
Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).
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.
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).
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.

Full Information

First Posted
March 23, 2015
Last Updated
May 11, 2021
Sponsor
Veryan Medical Ltd.
Collaborators
ClinLogix. LLC, Yale Cardiovascular Research Group, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02400905
Brief Title
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
Acronym
MIMICS-2
Official Title
MIMICS-2: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System in the Femoropopliteal Arteries of Patients With Symptomatic Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veryan Medical Ltd.
Collaborators
ClinLogix. LLC, Yale Cardiovascular Research Group, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
PAD, PVD, SFA stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioMimics 3D Vascular Stent
Arm Type
Experimental
Arm Description
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System
Intervention Type
Device
Intervention Name(s)
BioMimics 3D Vascular Stent System
Intervention Description
Femoropopliteal stenting
Primary Outcome Measure Information:
Title
Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)
Description
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.
Time Frame
30 days
Title
Primary Effectiveness Endpoint (Primary Stent Patency Rate)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary Safety (Overall MAE Rate at 30 Days)
Description
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.
Time Frame
30 Days
Title
Long Term Safety (Overall MAE Rate at Month 12)
Description
Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.
Time Frame
12 months
Title
Number of Participants With Serious Adverse Events
Description
Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.
Time Frame
36 Months
Title
Technical Success
Description
Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure
Time Frame
Procedural (at end of index procedure)
Title
Primary Stent Patency
Description
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.
Time Frame
Months 12 & 24
Title
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More
Description
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
Time Frame
Baseline, Day 30, Months 12 & 24
Title
Clinical Outcome (Six-Minute Walk Test)
Description
Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).
Time Frame
Baseline, Day 30, Months 12 & 24
Title
Functional Outcome (Ankle Brachial Index (ABI) Measurement)
Description
Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.
Time Frame
Baseline, Day 30, Months 12 & 24
Title
Change of Walking Impairment Questionnaire Score
Description
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).
Time Frame
Baseline, Day 30, Months 12 & 24
Title
Number of Participants With Freedom From Stent Fracture
Description
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.
Time Frame
Months 12, 24 & 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M. Sullivan, MD
Organizational Affiliation
Minneapolis Heart Institute / Abbott Northwestern Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, MD
Organizational Affiliation
Herz-Zentrum University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Masato Nakamura, MD
Organizational Affiliation
Toho University Ohashi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brookwood Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Cardiology Associates of Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Bradenton Cardiology Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
MediQuest Research Group/ Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Coastal Vascular
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Kings Daughters Medical Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Endovascular Technologies / Grace Research
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Michigan Outpatient Vascular Institute
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Michigan Vascular Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Minneapolis Heart
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Deborah Heart & Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
NC Heart & Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27067
Country
United States
Facility Name
WakeMed Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Pinnacle Health Harrisburg
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Berks Cardiologists
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
North Central Heart
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57018
Country
United States
Facility Name
Kore Cardiovascular Research
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Austin Heart Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Cardiovascular Specialist of TX / North Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Grace Research
City
Huntsville
State/Province
Texas
ZIP/Postal Code
77340
Country
United States
Facility Name
Mission Research Institute/Guadalupe Regional Medical Center
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Cardiovascular Associates of East Texas
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Karolinen-Hospital
City
Arnsberg
Country
Germany
Facility Name
Universitaets-Herzzentrum Freiburg-Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Diakonissenkrankenhaus Flensburg
City
Flensburg
Country
Germany
Facility Name
Westküstenklinikum Heide
City
Heide
Country
Germany
Facility Name
Universitätsklinikum Leipzig AoR Leipzig
City
Leipzig
Country
Germany
Facility Name
St. Bonifatius Hospital
City
Lingen
Country
Germany
Facility Name
Kansai Rosai Hospital
City
Hyogo
Country
Japan
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu-shi
Country
Japan
Facility Name
Morinomiya Hospital
City
Osaka
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Shiga
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33331207
Citation
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.
Results Reference
derived

Learn more about this trial

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

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