Clinical trial NCT02400905: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: PAD
PVD
SFA stent
Lead sponsor: Veryan Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ClinLogix. LLC
name: Yale Cardiovascular Research Group
name: Massachusetts General Hospital
First posted: 2015-03-27
Enrollment: 271
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)
timeFrame: 30 days
measure: Primary Effectiveness Endpoint (Primary Stent Patency Rate)
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Safety (Overall MAE Rate at 30 Days)
timeFrame: 30 Days
measure: Long Term Safety (Overall MAE Rate at Month 12)
timeFrame: 12 months
measure: Number of Participants With Serious Adverse Events
timeFrame: 36 Months
measure: Technical Success
timeFrame: Procedural (at end of index procedure)
measure: Primary Stent Patency
timeFrame: Months 12 & 24
measure: Number of Participants With Improvement of Rutherford Clinical Category by 1 or More
timeFrame: Baseline, Day 30, Months 12 & 24
measure: Clinical Outcome (Six-Minute Walk Test)
timeFrame: Baseline, Day 30, Months 12 & 24
measure: Functional Outcome (Ankle Brachial Index (ABI) Measurement)
timeFrame: Baseline, Day 30, Months 12 & 24
measure: Change of Walking Impairment Questionnaire Score
timeFrame: Baseline, Day 30, Months 12 & 24
measure: Number of Participants With Freedom From Stent Fracture
timeFrame: Months 12, 24 & 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Ocala
country: United States
facility: MediQuest Research Group/ Munroe Regional Medical Center
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular
state: Florida
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Ashland
country: United States
facility: Kings Daughters Medical Center
state: Kentucky
city: Bossier City
country: United States
facility: Endovascular Technologies / Grace Research
state: Louisiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Dearborn
country: United States
facility: Michigan Outpatient Vascular Institute
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart
state: Minnesota
city: Browns Mills
country: United States
facility: Deborah Heart & Lung Center
state: New Jersey
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Research
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Harrisburg
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Jackson
country: United States
facility: Kore Cardiovascular Research
state: Tennessee
city: Austin
country: United States
facility: Austin Heart Research
state: Texas
city: Austin
country: United States
facility: Cardiovascular Specialist of TX / North Austin Medical Center
state: Texas
city: Huntsville
country: United States
facility: Grace Research
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute/Guadalupe Regional Medical Center
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Arnsberg
country: Germany
facility: Karolinen-Hospital
city: Bad Krozingen
country: Germany
facility: Universitaets-Herzzentrum Freiburg-Bad Krozingen
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus Flensburg
city: Heide
country: Germany
facility: Westküstenklinikum Heide
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AoR Leipzig
city: Lingen
country: Germany
facility: St. Bonifatius Hospital
city: Hyogo
country: Japan
facility: Kansai Rosai Hospital
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
city: Osaka
country: Japan
facility: Morinomiya Hospital
city: Shiga
country: Japan
facility: Omihachiman Community Medical Center
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
Study officials:
affiliation: Minneapolis Heart Institute / Abbott Northwestern Hospital
name: Timothy M. Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz-Zentrum University Hospital
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toho University Ohashi Medical Center
name: Masato Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.