The GISE-ShockCalcium Registry - An Investigator Driven Italian All Comers Registry of Calcified Lesions Treated With Intravascular Lithotripsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Primary composite safety endpoint: Target lesion failure (TLF): Target lesion revascularization (TLR)
研究概览
简要总结
The GISE-SHOCKCALCIUM Registry is an Investigator Driven Italian All Comers prospective, observational, multicenter Italian IVL registry of Calcified lesions Treated with Intravascular Lithotripsy. The main purpose is to evaluate the efficacy and safety of coronary lithotripsy for treatment of severe calcified lesion. A total of 2000 patients with coronary calcified lesions will be enrolled in 24 months. The registry will be conducted in approximately 50 interventional cardiology centers in Italy with at least 2 IVL procedures per 24 months. Primary endpoint: Target lesion failure (TLF) at 1 year.
Secondary safety endpoints: in Hospital Target lesion failure (TLF); Target Lesion Failure at 30 days; definite or probable stent thrombosis; procedural angiographic safety endpoints. Secondary effectiveness endpoints: device crossing and IVL delivery success; angiographic success; QCA (quantitative coronary angiography) outcome; Imaging outcome.
详细描述
This is a prospective, observational, multicenter Italian IVL registry designed to evaluate the efficacy and safety of coronary lithotripsy for treatment of severe calcified lesion.
This registry is planned to be conducted at approximately 30-50 sites in Italy and to include a total of 2000 patients with coronary calcified lesions.
The Principal Investigators will approach all the Italian centers with at least 2 IVL procedures per month via the regional GISE Coordinator and based on the IVL volume of the various hospitals with IVL in the previous 18 months (excluding the period February-June 2020). Possible regulatory or budgetary constrictions expected to limit future application of IVL will also be considered. Centers should be approached by on-line questionnaires and during regional teleconferences to agree to collect data for all IVL procedures, fill a screening log for all calcified lesions, perform a complete clinical 1 year follow-up of all IVL patients, including collection of source documents for event adjudication. Participation in OCT (optical coherence tomography) or IVUS (Intravascular UltraSound) sub-studies (clinically mandated imaging) will be highly encouraged agreeing to perform documented pull-backs across the calcified treated/stented segment and provide images for off-line analysis from a central core laboratory.
The registry will consist of 3 essential parts: a screening period (patient and lesion selection), a treatment period (PCI with IVL lesion preparation and stent implantation), and a follow-up period (1 year).
Patients will be screened, according to the flowchart and stratified at baseline by angiographic evaluation or intravascular imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients is ≥ 18 years of age.
- •Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who require an IVL with the Shockwave catheter.
- •Presence of single or multiple calcifications at the lesion site defined by,
- •a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
- •Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life)
- •Ability to give written informed consent.
- •Patient is able and willing to comply with all follow-up assessments
排除标准
- •Refusal to participate in this study.
- •Calcific lesion within a > 4 mm reference segment of the vessel
- •Lesions in LIMA(left internal mammary artery)/RIMA (rightinternal mammary artery) or at the distal anastomosis of an SVG (saphenous vein grafts)
- •All the usual relative contraindications to coronary angioplasty according to the clinical practice:
- •Patient has active systemic infection
- •Patient has a known untreated coagulation disorder
- •Patient has allergy to imaging contrast media for which he/she cannot be pre-medicated
- •Patient is pregnant or nursing
- •Patients whose life expectancy is < 1 year
- •Patients due to move abroad within 1 year
结局指标
主要结局
Primary composite safety endpoint: Target lesion failure (TLF): Target lesion revascularization (TLR)
时间窗: at 1 year
defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion, clinically or ischemia driven
Primary composite safety endpoint: Target lesion failure (TLF): cardiovascular death
时间窗: at 1 year
Cardiovascular death defined as death resulting from cardiovascular causes: 1. death caused by acute MI 2. death caused by sudden cardiac arrest, including unwitnessed death 3. death resulting from heart failure 4. death caused by stroke 5. death caused by cardiovascular procedures 6. death resulting from cardiovascular hemorrhage 7. death resulting from other cardiovascular cause
Primary composite safety endpoint: Target lesion failure (TLF): Target-vessel Myocardial infarction (TV-MI)
时间窗: at 1 year
based on CK-MB level \>3x ULN with or without new pathologic Q-wave through discharge (peri-procedural MI) and using the 4th Universal Definition of MI beyond discharge
次要结局
- Secondary safety endpoints: in Hospital Target lesion failure (TLF)(at 1 year)
- Secondary safety endpoints: Procedural angiographic safety endpoints(at 1 year)
- Secondary safety endpoints: Target lesion failure(at 30 days)
- Secondary safety endpoints: Definite or probable stent thrombosis(at 1 year)
- Secondary effectiveness endpoints: Device crossing and IVL delivery success(at 1 year)
- Secondary effectiveness endpoints: Angiographic success(at 1 year)