Peripheral Arterial DiseaseNCT04640597
MIMICS-3D-USA Registry Study
An observational study of Peripheral Arterial Disease, run by Veryan Medical Ltd. at 27 sites in United States.
Trial summary
The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment… Read more about this study
- Who is it for?
- Ages 18 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
- How many people
- 500 participants
- Where
- 27 sitesUnited States
- Study dates
- 18 Dec 2020to 4 Sep 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who receive treatment with Veryan's BioMimics 3D Vascular Stent System in accordance with the current approved FDA (PMA # 180003 approval) indication for use as stated in the Instructions for Use (IFU) will be consecutively enrolled in this study
Who may be able to join
- Patient is age ≥18 and ≤85 years at the 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 Vascular Stent System in accordance with the IFU.
Who cannot join
- 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 or severe hypertension.
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Ascension Seton Heart Institute
Austin, Texas, 78705
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Cardiovascular Associates of the Southeast
Birmingham, Alabama, 35243
Cardiovascular Solutions Institute
Bradenton, Florida, 34208
Amputation Prevention Center of North Carolina
Cary, North Carolina, 27518
NJ Endovascular and Amputation Prevention, LLP
Clifton, New Jersey, 07013
University of Missouri
Columbia, Missouri, 65212
Vascular Care Connecticut
Darien, Connecticut, 06820
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52801
Coastal Vascular & Interventional, PLLC
Davenport, Iowa, 52807
CIS Clinical Research Corporation
Houma, Louisiana, 70360
Baylor St Lukes Medical Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
US cardiovascular of Greenburg
Jefferson Hills, Pennsylvania, 15025
North Dallas Research Associates
McKinney, Texas, 75609
Palm Vascular Centers
Miami Beach, Florida, 33140
AZH Wound & Vascular Center
Milwaukee, Wisconsin, 53221
Hurricane Cardiology Research
New Braunfels, Texas, 78130
Cardiac And Vascular Interventions of NJ
New Brunswick, New Jersey, 08901
Columbia University Irving Medical Center/NYPH
New York, New York, 10032
Columbia University Medical Center
New York, New York, 10032
Advanced Cardiovascular Solutions
Oklahoma City, Oklahoma, 73134
Coastal Vascular & Interventional, PLLC
Pensacola, Florida, 32504
Pulse Cardiovascular Institute
Scottsdale, Arizona, 85251
Washington University School of Medicine
St Louis, Missouri, 63110
Vascular Care Group
Wellesley, Massachusetts, 02482
About this study
Official title: A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Vascular Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D-USA
The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.
Read the detailed description
The MIMICS-3D-USA Study is designed to enable the collection, analysis, reporting and presentation of data from use of the BioMimics 3D Vascular Stent System purchased by the hospital / institution or office interventional suite and used in accordance with the IFU associated with the product's FDA approval. The intent of this post-market observational study is to increase the understanding of the performance of the BioMimics 3D Vascular Stent System in a larger population of patients representative of a real-world situation within US hospitals, institutions and office-based interventional suites or labs.
- Conditions
- Peripheral Arterial Disease
- Being tested
- BioMimics 3D Vascular Stent System
- Keywords
- PAD, PVD, SFA stent, stent, Helical stent, Vascular 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
Patients with BioMimics 3D Vascular Stent System
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint of number of subjects of freedom from CEC-adjudicated major adverse events (MAE) comprising death, any unplanned major amputation performed on the index limb or clinically driven target lesion revascularization (CDTLR) through 30 days.
Freedom from major adverse events expressed as a percentage
Measured: 30 Days
Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
Freedom from CDTLR at 12 Months expressed as a percentage
Measured: 12 months
Secondary outcomes (9)
Technical success defined as delivery and deployment of the study stent to achieve a final residual diameter stenosis of ≤30% measured by visual assessment of angiographic imaging at the end of the study procedure on Day 0.
Number of participants with final residual stenosis ≤30%
Measured: Procedural
Procedural success defined as technical success with absence of MAE (comprising death,
Number of participants with acute technical success and absence of MAE
Measured: 24 hours after index procedure
Incidence of components of CEC-adjudicated MAE.
Incidence of individual components of CEC-adjudicated MAE (death, any unplanned major amputation performed on the index limb or CDTLR).
Measured: 30 days, 12, 24 and 36 months
Overall rate and incidence of adverse events
Overall rate and incidence of adverse events from Day 0 to completion of study follow-up at month 36
Measured: 36 Months
Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months
Primary Stent Patency expressed as a percentage
Measured: 12 Months
Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.
Compare RCC at each of the follow-up visit with the Baseline
Measured: Baseline, Day 30, Months 12, 24 and 36.
Functional outcome: ankle brachial index measurement comparison
Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Month 12.
Measured: Baseline, within 30 days after index procedure, then at Month 12.
Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36
Compare the change in QoL score compared to the Baseline
Measured: Baseline, Day 30, Months 12, 24 and 36.
Incidence of stent fractures
Incidence of reported stent fracture reported by investigational sites through 36 months
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start18 Dec 2020
- Primary completion4 Sep 2023 (estimated)
- Study completion4 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Veryan Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nuwani Edirisinghe, Study director, Veryan Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640597
- Sponsor's protocol ID
- MIMICS-3D-USA
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentre Observational Study to Evaluate the BioMimics 3D Vascular Stent System in the Treatment of Peripheral Arterial Disease: MIMICS-3D-USA
- ClinicalTrials.gov ID
- NCT04640597
- Acronym / sponsor ID
- MIMICS-3D-USA
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, PVD, SFA stent, stent, Helical stent, Vascular stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Veryan Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 4 Sep 2023 (estimated)
- Study completion
- 4 Sep 2025 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.
Detailed description
The MIMICS-3D-USA Study is designed to enable the collection, analysis, reporting and presentation of data from use of the BioMimics 3D Vascular Stent System purchased by the hospital / institution or office interventional suite and used in accordance with the IFU associated with the product's FDA approval. The intent of this post-market observational study is to increase the understanding of the performance of the BioMimics 3D Vascular Stent System in a larger population of patients representative of a real-world situation within US hospitals, institutions and office-based interventional suites or labs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive treatment with Veryan's BioMimics 3D Vascular Stent System in accordance with the current approved FDA (PMA # 180003 approval) indication for use as stated in the Instructions for Use (IFU) will be consecutively enrolled in this study
Key inclusion criteria (3 listed)
- Patient is age ≥18 and ≤85 years at the 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 Vascular Stent System in accordance with the IFU.
Key exclusion criteria (6 listed)
- 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 or severe hypertension.
- 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.
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 SystemPatients with BioMimics 3D Vascular Stent System | Device | – |
Primary outcome
Safety endpoint of number of subjects of freedom from CEC-adjudicated major adverse events (MAE) comprising death, any unplanned major amputation performed on the index limb or clinically driven target lesion revascularization (CDTLR) through 30 days.
Time frame: 30 Days
Freedom from major adverse events expressed as a percentage
Primary effectiveness endpoint of number of subjects of freedom from CEC Adjudicated clinically driven target lesion revascularization (CDTLR) through 12 months
Time frame: 12 months
Freedom from CDTLR at 12 Months expressed as a percentage
9 secondary outcomes
Technical success defined as delivery and deployment of the study stent to achieve a final residual diameter stenosis of ≤30% measured by visual assessment of angiographic imaging at the end of the study procedure on Day 0.
Time frame: Procedural
Procedural success defined as technical success with absence of MAE (comprising death,
Time frame: 24 hours after index procedure
Incidence of components of CEC-adjudicated MAE.
Time frame: 30 days, 12, 24 and 36 months
Overall rate and incidence of adverse events
Time frame: 36 Months
Primary Stent Patency rate determined by core lab adjudicated, duplex ultrasound at 12 Months
Time frame: 12 Months
Comparison of mean Rutherford Clinical Category measured at Baseline, Day 30, Months 12, 24 and 36.
Time frame: Baseline, Day 30, Months 12, 24 and 36.
Functional outcome: ankle brachial index measurement comparison
Time frame: Baseline, within 30 days after index procedure, then at Month 12.
Comparison of the quality of life (QoL) score at Baseline, within 30 days after index procedure, then at Months 12, 24 and 36
Time frame: Baseline, Day 30, Months 12, 24 and 36.
Incidence of stent fractures
Time frame: 36 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Nuwani Edirisinghe study director
Veryan Medical
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Veryan Medical Ltd. at 27 sites in United States.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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?
Results are not available in the source record.
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?
Safety endpoint of number of subjects of freedom from CEC-adjudicated major adverse events (MAE) comprising death, any unplanned major amputation performed on the index limb or clinically driven target lesion revascularization (CDTLR) through 30 days. (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?
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 16 Nov 2022.