Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Minimum stent area (MSA)
研究概览
简要总结
The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).
详细描述
The trial consists of two cohorts:
- Patients with calcified nodules (CN) (Cohort A)
- Patients with non-nodular severe coronary calcium (Cohort B)
Randomization will occur as follows:
- Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A).
- Operator-determined or maximum IVL pulses prior to stenting. (Cohort B)
The trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at the CN site (Cohort A) and at the site of maximum calcification (Cohort B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to treatment allocation. Operators and investigators are unblinded.
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
- •Age ≥18 years who signed written informed consent
- •Presence of a clinical indication for coronary intervention
- •Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation
- •Native coronary artery with significant stenosis defined as:
- •≥70% and <100% stenosis on angiography, or
- •50-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area (MLA) ≤ 4.0 mm2)
- •Reference vessel diameter: ≥2.5 mm to ≤ 4.0 mm
- •Lesion length: ≥5mm
- •Moderate to severe calcification of the target lesion confirmed by angiography
- •Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline
排除标准
- •Cardiogenic shock at the time of procedure
- •Primary PCI for ST-segment elevation myocardial infarction (STEMI)
- •Pregnant, nursing, or childbearing potential without adequate contraception
- •Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
- •Planned surgery within 6 months unless DAPT can be maintained
- •Life expectancy <12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure)
- •Severe kidney dysfunction (CrCl <30 mL/min) without dialysis
- •Concurrent participation in another investigational study
- •Referral for coronary artery bypass grafting (CABG) after a heart team discussion
- •Angiographic evidence of thrombus at the target lesion
- •Angiographic evidence of significant dissection at the treatment site prior to intervention
- •Lesion with a previously placed stent within 10mm (visual estimate)
- •Last remaining vessel with severely compromised left ventricular function (LVEF <30%)
- •Target lesion within a saphenous vein graft (SVG)
研究组 & 干预措施
RA + IVL (Cohort A)
Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.
干预措施: Intravascular lithotripsy (Device)
RA + IVL (Cohort A)
Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.
干预措施: Rotational atherectomy (Device)
IVL alone (Cohort A)
Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting.
干预措施: Intravascular lithotripsy (Device)
Maximum IVL pulses (Cohort B)
Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions.
干预措施: Intravascular lithotripsy (Device)
Operator-determined IVL pulses (Cohort B)
Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion.
干预措施: Intravascular lithotripsy (Device)
结局指标
主要结局
Minimum stent area (MSA)
时间窗: Immediately after Index procedure
Post-procedural minimum stent area measured at the site of the calcified nodule (Cohort A) or the point of maximum calcification (Cohort B), as assessed by optical coherence tomography (OCT)
次要结局
- Pre- and post-dilatation ballon size(Immediately before and after Index procedure)
- Pre- and post-dilatation inflation pressure(Immediately before and after Index procedure)
- Bailout or adjunctive calcium modification(Intraoperatively during Index procedure)
- Number of Calcium fractures(Immediately after Index procedure)
- Target vessel failure (TVF)(during hospitalization, approximately 1-2 days, 30 days, and 12 months)
- Stent thrombosis(12 months)
- Device success(Immediately after Index procedure)
- Angiographic success(Immediately after Index procedure)
- Procedural success(Immediately after Index procedure)
- Total number of IVL pulses delivered to the lesion during treatment(Intraoperatively during Index procedure)
- Lesion length of IVL pulses delivered(Intraoperatively during Index procedure)
研究者
Annapoorna Kini
Professor
Icahn School of Medicine at Mount Sinai