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

Peripheral Arterial Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400905
• Other study ID #: CID-100
• Status: Completed
• Phase: N/A
• Start date: June 29, 2015
• Est. completion date: December 3, 2019

Study information

• Verified date: May 2021
• Source: Veryan Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 3, 2019
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• BioMimics 3D Vascular Stent System
Femoropopliteal stenting

Locations

Country	Name	City	State
Germany	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
Japan	Kansai Rosai Hospital	Hyogo
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
United States	Kings Daughters Medical Center	Ashland	Kentucky
United States	Austin Heart Research	Austin	Texas
United States	Cardiovascular Specialist of TX / North Austin Medical Center	Austin	Texas
United States	Brookwood Medical Center	Birmingham	Alabama
United States	Endovascular Technologies / Grace Research	Bossier City	Louisiana
United States	Bradenton Cardiology Center	Bradenton	Florida
United States	Deborah Heart & Lung Center	Browns Mills	New Jersey
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Michigan Outpatient Vascular Institute	Dearborn	Michigan
United States	St. John Hospital & Medical Center	Detroit	Michigan
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Michigan Vascular Center	Flint	Michigan
United States	Pinnacle Health Harrisburg	Harrisburg	Pennsylvania
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Grace Research	Huntsville	Texas
United States	Kore Cardiovascular Research	Jackson	Tennessee
United States	Cardiovascular Institute of the South	Lafayette	Louisiana
United States	Minneapolis Heart	Minneapolis	Minnesota
United States	Cardiology Associates of Mobile	Mobile	Alabama
United States	Mission Research Institute/Guadalupe Regional Medical Center	New Braunfels	Texas
United States	Yale New Haven Hospital	New Haven	Connecticut
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	Arizona Heart Hospital	Phoenix	Arizona
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	WakeMed Research	Raleigh	North Carolina
United States	North Central Heart	Sioux Falls	South Dakota
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Cardiovascular Associates of East Texas	Tyler	Texas
United States	Berks Cardiologists	Wyomissing	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Veryan Medical Ltd.	ClinLogix. LLC, Massachusetts General Hospital, Yale Cardiovascular Research Group

Countries where clinical trial is conducted

United States,  Germany,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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