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A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included in the registry.
The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.
STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.
Primary objective:
MACE rate at 12 months of follow-up:
Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).
Secondary objectives:
Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BVS patients | Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions. |
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| Measure | Description | Time Frame |
|---|---|---|
| MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR | Clinical follow-up at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate success of the device/procedure | 1 day | |
| Cardiac death | 12 months | |
| Myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with native coronary artery de novo lesions with indication for revascularization with a coronary device
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Hernandez, MD | Seccion Hemodinamica y Cardiologia Intervencionista | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Madrid | Madrid | 28041 | Spain |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12 months |
| Scaffold/Stent Thrombosis: Timing and Evidence | 12 months |
| Target lesion/vessel revascularization (TLR/TVR) | 12 months |
| Angina Events | 12 months |
| Rate of patients with DAPT at 12 months | 12 months |
| Rate of overlapping devices and characteristics | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |