Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT02900924
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 507
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants Free From Major Adverse Events (MAE) 30 days Primary Safety Endpoint: Number of participants free from a 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.
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR) 12 months Primary Effectiveness Endpoint: Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.
- Secondary Outcome Measures
Name Time Method Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure Within 72 hours of the index procedure. Acute Technical Success: Number of participants with a final residual diameter stenosis ≤30% within 72 hours of the index procedure.
Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description Within 72 hours of index procedure. Acute Procedural Success: Number of participants with acute technical success (achievement of a final stenosis ≤30% at the end of the procedure) 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 hours of index procedure.
Number of Participants With Adverse Events 30 day, 12 and 24 months Overall rate of all adverse events reported from Day 0 through 24 months. An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, whether or not related to the investigational device or procedure. For the purpose of this Study all potentially device-related and procedure-related adverse events, major adverse events (death, major amputation on the target limb, clinically-driven target lesion revascularisation), all vascular adverse events in the target limb, and serious adverse events are reported throughout the Study.
Stent Patency Rate 12 and 24 months. Per Protocol, patency is defined as the composite of freedom from more than 50% restenosis within the stented segment as observed by Duplex Ultrasound or Angiography within the visit window and freedom from clinically-driven target lesion revascularisation prior to the indicated time point. Stent patency rate assessed by duplex ultrasound (DUS), as available, determined at Months 12 and 24. This will be assessed using values of peak systolic velocity ratio (PSVR) \>2.0, \>2.4; \>2.5; and \>3.5. PSVR values of \>2.0, \>2.4, \>2.5 and \>3.5 were selected to compare outcomes from similar studies. There are no official definitions or guidelines on these values and which are most accurate for detection of \>50% stenosis, so all have been used in the analyses to compare results from other studies. PSVR of \>2.4, was looked at further as there are some studies that state this is the most established threshold for the detection of \>50% stenosis (Schlager, et al. 2007).
Percent Probability of Individual Components of MAE 30 days, 12 Months, and 24 Months. A Kaplan-Meier (KM) analysis of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 24 months.
Comparison of Rutherford Clinical Category Baseline, Day 30, 12 months and 24 months Clinical Outcome: Comparison of Rutherford Clinical Category (RCC) measured at Baseline, Day 30, Months 12 and 24. Rutherford Clinical Category is a clinical scale identifying three grades of claudication (RCC 1-3) and three grades of critical limb ischemia (RCC 4-6) ranging from rest pain alone to minor and major tissue loss. Category and clinical description: 0 - Asymptomatic, 1 - Mild claudication 2 - Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.
Comparison of Ankle Brachial Index (ABI) Measurement Baseline, Day 30, 12-month and 24-month. Functional outcome: Mean and standard deviation of the Ankle Brachial Index at each follow-up visit is reported.
The change of Ankle Brachial Index at 30 days, 12 and 24 months compared to Baseline is presented for the total number of patients where data were recorded, and the mean and standard deviation of the change.
ABI is the ratio of blood pressure measured at the ankle to blood pressure measured at the arms. It is used to predict the severity of peripheral arterial disease. An ABI of \>0.9-1.2 is considered normal, ≤ 0.9 indicates mild to moderate peripheral arterial disease, \< 0.4 indicates severe peripheral arterial disease (ischemic pain and ulceration).Number of Participants With Reported Stent Fracture 30 day, 12 and 24 Months. Site reported number of participants with stent fracture through 24 months. Stent fracture is defined as clear interruption of stent strut observed in a minimum of two projections, determined by examination of X-ray images.
Stent Strut Fracture Types: Type 0: No strut fractures. Type I: Single strut fracture only. Type II: Multiple single strut fractures that can occur at different sites. Type III: Multiple strut fractures resulting in complete transection of the stent, without displacement of the stent segments. Type IV: Multiple strut fractures resulting in displacement of segments of the stent. Type V: Spiral strut fracture.
Trial Locations
- Locations (23)
OLV Hospital
🇧🇪Aalst, Belgium
ZNA Vascular Clinic/ZNA Stuivenburg Hospital
🇧🇪Antwerp, Belgium
AZ Sint Blasius
🇧🇪Dendermonde, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Regionaal Vaartcentrum , AZ Helig Hart Tienen
🇧🇪Tienen, Belgium
Karolinen-Hospital
🇩🇪Arnsberg, Germany
Universitaets-Herzzentrum Freiburg-Bad Krozingen
🇩🇪Bad Krozingen, Germany
KEH Berlin
🇩🇪Berlin, Germany
Vivantes Klinikum Friedrichshain
🇩🇪Berlin, Germany
Krankenhaus Buchholz
🇩🇪Buchholz, Germany
Krankenhaus Dresden-Friedrichstadt, Städtisches Klinikum
🇩🇪Dresden, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
CCB im Agaplesion Bethanien Krankenhaus
🇩🇪Frankfurt am Main, Germany
Asklepios Klinik Harburg
🇩🇪Hamburg, Germany
UKE (University Hospital Hamburg)
🇩🇪Hamburg, Germany
Universitätsklinikum Leipzig AöR
🇩🇪Leipzig, Germany
Gefäßpraxis im Tal
🇩🇪Munich, Germany
Marienhospital Osnabrück GmbH
🇩🇪Osnabruck, Germany
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Germany
SRH-Klinikum Zentralklinikum Suhl
🇩🇪Suhl, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Skane University Hospital
🇸🇪Malmö, Sweden