A Prospective Evaluation of a Standardized Strategy for the Use of Bioresorbable Vascular Scaffold in ST-segment Elevation Myocardial Infarction: the BVS STEMI STRATEGY-IT Registry
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Device oriented composite end-point (DOCE)
研究概览
简要总结
BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary intervention (PPCI) with BVS implantation on the basis of the pre-specified inclusion and exclusion criteria.
This registry has the objective to assess the immediate (peri-procedural and 30 days), mid (6 months and 1 year) and long-term (3 and 5 years) results following BVS implantation using a pre-specified implantation strategy during PPCI in STEMI subjects.
详细描述
Population:
This registry is intended to obtain data from consecutive STEMI patients undergoing PPCI with BVS implantation in 10-15 Italian sites.
STEMI is defined according to the European guidelines criteria.
Procedure:
Dual Anti-Platelet and Antithrombotic Regimen:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with a ST-elevation myocardial infarction (STEMI) with symptoms onset <12 hours from hospital admission eligible for PPCI and BVS implantation;
- •Signed Patient Informed Consent/Data Release Form.
排除标准
- •Age >75 years or <18 years;
- •Cardiogenic shock;
- •Pregnancy or breastfeeding;
- •Infarct-artery max diameter (within planned device deployment segment) <2.5 or >3.7 mm;
- •Stent thrombosis/restenosis as a culprit lesion;
- •Acute occlusion of a saphenous vein graft as a culprit lesion;
- •Culprit lesion involving a bifurcation which requires a 2-stent strategy as intention-to-treat;
- •Culprit lesion involving a long diseased segment requiring hybrid (overlap BVS-DES) treatment;
- •Comorbidities with life expectancy <3 years;
- •Contraindication to 12 months dual anti-platelet therapy;
- •Severe calcification or/tortuosity in the segments proximal to the culprit lesion;
- •Absolute indication to chronic anticoagulation therapy;
- •Elective or emergent cardiac surgery intervention within 1 year after PPCI (i.e. inferior STEMI with critical unprotected left main disease or mechanical complications of STEMI).
研究组 & 干预措施
Primary PCI (PPCI) with BVS
Primary percutaneous coronary intervention (PPCI) with bioresorbable vascular scaffold (BVS) implantation in STEMI patients. Following the arterial route, PPCI (performed according to the international guidelines) aims to recanalize an occluded coronary artery that is then maintained patent inserting an endovascular permanent prosthesis (stent). In this study we aim to assess the results following the use of a fully bioresorbable prosthesis (BVS) during PPCI using a pre-specified implantation strategy (eventual thrombectomy, intravascular imaging, lesion pre-dilatation, BVS implantation and BVS post-dilatation). BVS has the theoretical advantage, as compared with a permanent stent, to disappear within 24-36 months from implantation restoring the native pristine vessel state.
干预措施: Primary percutaneous coronary intervention (PPCI) (Procedure)
Primary PCI (PPCI) with BVS
Primary percutaneous coronary intervention (PPCI) with bioresorbable vascular scaffold (BVS) implantation in STEMI patients. Following the arterial route, PPCI (performed according to the international guidelines) aims to recanalize an occluded coronary artery that is then maintained patent inserting an endovascular permanent prosthesis (stent). In this study we aim to assess the results following the use of a fully bioresorbable prosthesis (BVS) during PPCI using a pre-specified implantation strategy (eventual thrombectomy, intravascular imaging, lesion pre-dilatation, BVS implantation and BVS post-dilatation). BVS has the theoretical advantage, as compared with a permanent stent, to disappear within 24-36 months from implantation restoring the native pristine vessel state.
干预措施: Bioresorbable Vascular Scaffold (BVS ABSORB) (Device)
结局指标
主要结局
Device oriented composite end-point (DOCE)
时间窗: 30 days
A device oriented composite end-point of cardiac death, any myocardial infarction (STEMI or NSTEMI) clearly attributable to the-intervention culprit vessel (TV-MI) and ischemic driven TLR within 30 days after the index procedure.
次要结局
- Major adverse cardiovascular events (MACE)(In Hospital and at follow-up (up to 5 years))
- Procedural Success(0-7 days)
- BVS Thrombosis(In Hospital and at follow-up (up to 5 years))
- Device oriented composite end-point (DOCE)(6 months; 1, 3, 5 years)
- Any Bleeding(In Hospital and at follow-up (up to 5 years))
- ST-segment resolution at the electrocardiogram (ECG)(60 minutes)
研究者
Alfonso Ielasi
MD
Azienda Ospedaliera Bolognini di Seriate Bergamo