Ischemia Clinical Trial
Official title:
A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT
NCT number | NCT03461484 |
Other study ID # | 13-EU-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 6, 2014 |
Est. completion date | October 31, 2019 |
Verified date | May 2019 |
Source | Biosensors Europe SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.
Status | Completed |
Enrollment | 2098 |
Est. completion date | October 31, 2019 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - "Real world, all comer" patients 1. Age =18 years; 2. Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent; 3. Presence of one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents; 4. No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements; 5. Patient with DAPT indication after PCI. Exclusion Criteria: 1. Inability to provide informed consent; 2. Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types; 3. Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation; 4. Pregnant or planning to become pregnant patient; 5. DES and BMS implantation less than 6 months before screening; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Biosensors Europe SA | European Cardiovascular Research Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months | Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months | 6 months | |
Secondary | Primary and secondary stent thrombosis | Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years; | 6 months and 2 years | |
Secondary | Major bleeding | Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years | 6 months and 2 years | |
Secondary | Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population | Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population, defined as composite of all cause death, myocardial infarction (Q-wave and non-Q-wave), cerebrovascular accidents or clinically-driven target vessel revascularization at 2 years | 2 years | |
Secondary | Cardiac deaths at 6 months and and 2 years | Cardiac deaths at 6 months and and 2 years | 6 months and and 2 years | |
Secondary | Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years | Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years | 6 months and 2 years | |
Secondary | Death,MI and cerebrovascular accidents at 6 months and 2 years | Death,MI and cerebrovascular accidents at 6 months and 2 years | 6 months and 2 years | |
Secondary | Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years | Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years | 6 months and 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05443061 -
Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children
|
N/A | |
Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
Recruiting |
NCT06006975 -
Early Warning of Delayed Cerebral Ischemia
|
||
Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
Completed |
NCT02758847 -
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
|
N/A | |
Completed |
NCT02557282 -
CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol
|
||
Enrolling by invitation |
NCT02033681 -
Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
|
N/A | |
Completed |
NCT01608035 -
Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
|
Phase 0 | |
Active, not recruiting |
NCT01518842 -
Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
|
N/A | |
Completed |
NCT01625832 -
Effects of Coronary Sinus Occlusion on Myocardial Ischemia (Pilot Study)
|
N/A | |
Active, not recruiting |
NCT01281241 -
Study on Mechanical and Electrical Alternans
|
N/A | |
Completed |
NCT00778323 -
Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT00371371 -
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
|
Phase 1/Phase 2 | |
Terminated |
NCT00760708 -
Circulating Adenosine Levels Before and After Intravenous (IV) Persantine
|
||
Not yet recruiting |
NCT06039748 -
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
|
||
Completed |
NCT04879875 -
New Method for Real-time Detection of Tissue Ischemia (ISCALERT)
|
N/A | |
Completed |
NCT00526474 -
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)
|
Phase 3 | |
Completed |
NCT03994822 -
pRESET for Occlusive Stroke Treatment
|
N/A | |
Completed |
NCT02910778 -
The Effect of Ticagrelor With or Without Atorvastatin on Endothelial Function in Healthy Males
|
Phase 4 | |
Completed |
NCT02552498 -
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
|
N/A |