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Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D (MIMICS-3D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900924
Recruitment Status : Active, not recruiting
First Posted : September 15, 2016
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Veryan Medical Ltd.

Brief Summary:
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: BioMimics 3D Stent

Detailed Description:

The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D Stent System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial disease of the femoropopliteal artery. The study is designed to enable the collection, analysis and reporting of data from "real-world" use of the BioMimics 3D Stent System used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.

Data collection will include that relating to safety, effectiveness and device performance and the period of observation during which data will be collected will extend from the index procedure through 3 years (36 months), according to the standard follow-up practice of the enrolling institution.

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Study Type : Observational
Actual Enrollment : 507 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Self-Expanding Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D
Actual Study Start Date : September 2016
Actual Primary Completion Date : October 2019
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Freedom from a composite of major adverse events (MAE) (Primary Safety Endpoint) [ Time Frame: 30 days ]
    Number of participants free from composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days.

  2. Freedom from clinically-driven target lesion revascularization (CDTLR) (Primary Effectiveness Endpoint) [ Time Frame: 12 months ]
    Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.


Secondary Outcome Measures :
  1. Acute technical success defined as achievement of a final residual diameter stenosis ≤30% at the end of the procedure [ Time Frame: Procedural ]
    Number of participants with final residual diameter stenosis ≤30% at the end of the index procedure

  2. Acute procedural success defined as acute technical success and absence of peri-procedural adverse events. [ Time Frame: 72 hours ]
    Number of participants with acute technical success and absence of the following adverse events: death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 h of the index procedure.

  3. Incidence of individual components of MAE [ Time Frame: 30 days, 12, 24 and 36 months ]
    Incidence of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 36 months

  4. Overall rate and incidence of adverse events from Day 0 through completion of study follow-up at Month 36. [ Time Frame: 36 months ]
    Overall rate and incidence of all adverse events reported from Day 0 through completion of study follow-up at Month 36.

  5. Stent patency [ Time Frame: 12, 24 and 36 months ]
    Stent patency rate assessed by duplex ultrasound, as available, determined at Months 12, 24 and 36. This will be assessed using values of peak systolic velocity ratio (PSVR) >2.0, >2.4; >2.5; and >3.5 each to indicate loss of patency on duplex ultrasound.

  6. Rutherford Clinical Category [ Time Frame: Baseline, Day 30, Months 12 24 and 36 ]
    Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 24 and 36.

  7. Functional outcome (ankle brachial index (ABI) measurement) [ Time Frame: Baseline, Day 30, Months 12, 24 and 36. ]
    Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who receive treatment with Veryan's BioMimics 3D Stent System in accordance with the current approved CE Mark indication for use as stated in the Instructions for Use (IFU) will be consecutively enroled in this study.
Criteria

Inclusion Criteria:

  • Patient is age ≥18 and ≤85 years at date of consent.
  • Patient has provided written informed consent for participation in the study prior to index procedure.
  • Patient has documented symptomatic peripheral arterial disease scheduled for treatment with the BioMimics 3D stent in accordance with the approved CE Mark indication and Instructions for Use (IFU)

Exclusion Criteria:

  • Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system.
  • Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation therapies, bleeding diathesis, severe hypertension or renal failure.
  • Patients with known hypersensitivity to nickel-titanium.
  • Patient has a comorbidity that in the Investigator's opinion would limit life expectancy to less than 12 months.
  • Patient is pregnant or breastfeeding.
  • Patient is unable or is unwilling to comply with site standard of care procedures and follow-up visit schedules for patients undergoing femoropopliteal intervention.

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): NCT02900924


Locations
Show Show 25 study locations
Sponsors and Collaborators
Veryan Medical Ltd.
Investigators
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Principal Investigator: Michael Lichtenberg, MD Klinikum Arnsberg

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Responsible Party: Veryan Medical Ltd.
ClinicalTrials.gov Identifier: NCT02900924    
Other Study ID Numbers: MIMICS-3D
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Keywords provided by Veryan Medical Ltd.:
PAD
PVD
SFA stent
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases