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

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ClinicalTrials.gov Identifier: NCT02400905
Recruitment Status : Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
ClinLogix. LLC
Yale Cardiovascular Research Group
Massachusetts General Hospital
Information provided by (Responsible Party):
Veryan Medical Ltd.

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: BioMimics 3D Stent System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 271 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 29, 2015
Actual Primary Completion Date : November 8, 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioMimics 3D Stent
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Device: BioMimics 3D Stent System
Femoropopliteal stenting




Primary Outcome Measures :
  1. Primary Safety Endpoint (composite of major adverse events (MAE) [ Time Frame: 30 days ]
    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.

  2. Primary Effectiveness Endpoint (Primary stent patency rate) [ Time Frame: 12 months ]
    Primary stent patency rate at 12 months.


Secondary Outcome Measures :
  1. Secondary safety (overall MAE rate at 30 days) [ Time Frame: 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.

  2. Long term safety (Overall MAE rate at Month 12) [ Time Frame: 12 months ]
    Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.

  3. Long term Safety (Overall rate and incidence of type of serious adverse events) [ Time Frame: 36 Months ]
    Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.

  4. Technical Success ( percentage of treated lesions in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure) [ Time Frame: Procedural ]
    Technical success reported by the core lab as the

  5. Primary stent patency [ Time Frame: Months 12 & 24 ]
    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.

  6. Clinical outcome (Rutherford Clinical Category) [ Time Frame: Baseline, Day 30, Months 12 & 24 ]
    Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.

  7. Clinical outcome (Six-Minute Walk Test) [ Time Frame: Baseline, Day 30, Months 12 & 24 ]
    Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).

  8. Functional outcome (ankle brachial index (ABI) measurement) [ Time Frame: Day 30, Months 12 & 24 ]
    Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.

  9. Functional outcome (Walking Impairment Questionnaire) [ Time Frame: Baseline, Day 30, Months 12 & 24 ]
    Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.

  10. Stent integrity (measured as freedom from stent fracture) [ Time Frame: Months 12, 24 & 36 ]
    Stent integrity measured as freedom from stent fracture.



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400905


  Show 43 Study Locations
Sponsors and Collaborators
Veryan Medical Ltd.
ClinLogix. LLC
Yale Cardiovascular Research Group
Massachusetts General Hospital
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

Responsible Party: Veryan Medical Ltd.
ClinicalTrials.gov Identifier: NCT02400905     History of Changes
Other Study ID Numbers: CID-100
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Veryan Medical Ltd.:
PAD
PVD
SFA stent

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases