Peripheral Arterial DiseaseMIMICS-2NCT02400905
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
A study testing BioMimics 3D Vascular Stent System in people with Peripheral Arterial Disease, run by Veryan Medical Ltd. at 43 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- BioMimics 3D Vascular Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 43 sitesin 3 countries
- Study dates
- 29 Jun 2015to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
43 sites in 3 countries.
43 sites in 3 countries
United States31 sites
Kings Daughters Medical Center
Ashland, Kentucky, 41101
Austin Heart Research
Austin, Texas, 78756
Cardiovascular Specialist of TX / North Austin Medical Center
Austin, Texas, 78758
Brookwood Medical Center
Birmingham, Alabama, 35243
Endovascular Technologies / Grace Research
Bossier City, Louisiana, 71111
Bradenton Cardiology Center
Bradenton, Florida, 34205
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015
Riverside Methodist Hospital
Columbus, Ohio, 43214
Michigan Outpatient Vascular Institute
Dearborn, Michigan, 48126
St. John Hospital & Medical Center
Detroit, Michigan, 48236
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Michigan Vascular Center
Flint, Michigan, 48507
Pinnacle Health Harrisburg
Harrisburg, Pennsylvania, 17043
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Grace Research
Huntsville, Texas, 77340
Kore Cardiovascular Research
Jackson, Tennessee, 38305
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503
Minneapolis Heart
Minneapolis, Minnesota, 55407
Cardiology Associates of Mobile
Mobile, Alabama, 36532
Mission Research Institute/Guadalupe Regional Medical Center
New Braunfels, Texas, 78130
Yale New Haven Hospital
New Haven, Connecticut, 06510
MediQuest Research Group/ Munroe Regional Medical Center
Ocala, Florida, 34471
Coastal Vascular
Pensacola, Florida, 32504
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Arizona Heart Hospital
Phoenix, Arizona, 85006
NC Heart & Vascular Research
Raleigh, North Carolina, 27067
WakeMed Research
Raleigh, North Carolina, 27610
North Central Heart
Sioux Falls, South Dakota, 57018
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
Berks Cardiologists
Wyomissing, Pennsylvania, 19610
Germany6 sites
Karolinen-Hospital
Arnsberg
Universitaets-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen
Diakonissenkrankenhaus Flensburg
Flensburg
Westküstenklinikum Heide
Heide
Universitätsklinikum Leipzig AoR Leipzig
Leipzig
St. Bonifatius Hospital
Lingen
Japan6 sites
Kansai Rosai Hospital
Hyōgo
Kasukabe Chuo General Hospital
Kasukabe
Kokura Memorial Hospital
Kitakyushu-shi
Morinomiya Hospital
Osaka
Omihachiman Community Medical Center
Shiga
Toho University Ohashi Medical Center
Tokyo
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- BioMimics 3D Vascular Stent System
- Keywords
- PAD, PVD, SFA stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMimics 3D Vascular Stent SystemDevice
Femoropopliteal stenting
| Study group | Role | What they receive |
|---|---|---|
| BioMimics 3D Vascular Stent | Experimental | Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System Receives: Device: BioMimics 3D Vascular Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 36 Months
Technical Success
Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Months 12, 24 & 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start29 Jun 2015
- Primary completion3 Nov 2017
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veryan Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC, Yale Cardiovascular Research Group, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Timothy M. Sullivan, MD, Principal investigator, Minneapolis Heart Institute / Abbott Northwestern HospitalThomas Zeller, MD, Principal investigator, Herz-Zentrum University HospitalMasato Nakamura, MD, Principal investigator, Toho University Ohashi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400905
- Sponsor's protocol ID
- CID-100
- Acronym
- MIMICS-2
- Status last verified
- May 2021
- First submitted
- 23 Mar 2015
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 33331207
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02400905
- Acronym / sponsor ID
- MIMICS-2 / CID-100
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, PVD, SFA stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Veryan Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC, Yale Cardiovascular Research Group, Massachusetts General Hospital
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 18 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioMimics 3D Vascular Stent | Experimental | Device: BioMimics 3D Vascular Stent SystemImplantation of BioMimics 3D nitinol stent using the BioMimics 3D Vascular Stent System |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMimics 3D Vascular Stent SystemFemoropopliteal stenting | Device | BioMimics 3D Vascular Stent |
Primary outcome
Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)
Time frame: 30 days
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)
Time frame: 12 months
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.
10 secondary outcomes
Secondary Safety (Overall MAE Rate at 30 Days)
Time frame: 30 Days
Long Term Safety (Overall MAE Rate at Month 12)
Time frame: 12 months
Number of Participants With Serious Adverse Events
Time frame: 36 Months
Technical Success
Time frame: Procedural (at end of index procedure)
Primary Stent Patency
Time frame: Months 12 & 24
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More
Time frame: Baseline, Day 30, Months 12 & 24
Clinical Outcome (Six-Minute Walk Test)
Time frame: Baseline, Day 30, Months 12 & 24
Functional Outcome (Ankle Brachial Index (ABI) Measurement)
Time frame: Baseline, Day 30, Months 12 & 24
Change of Walking Impairment Questionnaire Score
Time frame: Baseline, Day 30, Months 12 & 24
Number of Participants With Freedom From Stent Fracture
Time frame: Months 12, 24 & 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33331207Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy M. Sullivan, MD principal investigator
Minneapolis Heart Institute / Abbott Northwestern Hospital
Thomas Zeller, MD principal investigator
Herz-Zentrum University Hospital
Masato Nakamura, MD principal investigator
Toho University Ohashi Medical Center
43 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioMimics 3D Vascular Stent System in people with Peripheral Arterial Disease, run by Veryan Medical Ltd. at 43 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.