NCT04319666Unknown不适用
Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Primary effectiveness endpoint 1
研究概览
简要总结
The IVL Left Main study is a prospective non-randomised pilot study to investigate the mechanical and procedural outcomes and safety of distal left main stenting with coronary lithotripsy in addition to standard techniques in patients with calcific left main disease and a clinical indication for revascularisation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years old.
- •Unprotected distal LM (or equivalent) disease defined as:
- •>70% diameter stenosis (DS) on angiography in the distal LM; or
- •≥50% DS in the distal LM with a) non-invasive evidence of ischaemia referable to a hemodynamically significant left main lesion, and/or b) FFR ≤0.80; or
- •>70% diameter stenosis in either the ostial left anterior descending (LAD) or ostial left circumflex (LCX) that is within 10 mm of the ostium and requires stenting back into the LM (distal LM equivalent); or
- •>50% diameter stenosis in either the ostial left anterior descending (LAD) or ostial left circumflex (LCX) that is within 10 mm of the ostium and requires stenting back into the LM (distal LM equivalent) with a) non-invasive evidence of ischaemia referable to its myocardial territory and/or b) FFR ≤0.80
- •Clinical indication for revascularisation by PCI
- •Viability of the treatment vessel as determined by echocardiography, cardiac MRI or other equivalent imaging modality.
- •≥ 270° arc of calcification within at least one stenotic segment demonstrated on intravascular imaging.
- •Ability to pass a 0.014" guide wire across the lesion.
- •Ability to provide informed consent and comply with all study procedures, including follow-up at 30 days.
- •Lesions not related to the distal LM requiring PCI can be treated:
- •at the time of the study procedure if completed prior to distal LM PCI and the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation. In situations where the distal LM lesion is critical, the LM can be ballooned or treated first so long as the study protocol is not deviated.
- •as a staged procedure either within the same hospital admission or within 30 days. Any staged procedure must be declared at the index procedure otherwise it will be recorded as an event.
排除标准
- •Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
- •Daughter vessel reference diameter < 2.5 mm.
- •Use of rotational atherectomy, scoring or cutting balloon, or any investigational device.
- •Evidence of aneurysm in target vessel within 10 mm of the target lesion.
- •Prior PCI of the LM or PCI of the proximal LAD or proximal LCX within 10 mm of the ostium.
- •Prior coronary artery by-pass graft (CABG) surgery.
- •Chronic total occlusion (CTO) of the LM, proximal LAD or proximal LCX.
- •Untreated pre-procedural haemoglobin < 8 g/dL.
- •Renal failure with serum creatinine > 2.5 mg/dL and not on chronic dialysis.
- •Uncontrolled diabetes defined as a HbA1c >10%.
- •Coagulopathy manifested by platelet count < 50,000/ mL or International Normalized ratio (INR) > 1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrolment).
- •Cardiogenic shock.
- •Ongoing ST elevation myocardial infarction (STEMI).
- •History of stroke or transient ischemic attack (TIA) within 3 months.
- •NYHA class IV heart failure or LVEF < 20%.
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months.
- •Patients with a life expectancy of less than 1 year.
- •Visible thrombus (by angiography) at target lesion site.
- •Patient has active systemic infection on the day of the index procedure with either fever or requiring intravenous antibiotics.
- •Patient has vascular connective tissue disease (e.g. Marfan's syndrome).
- •Patient has a hypercoagulable disorder.
- •Patient has allergy to imaging contrast media for which they cannot be pre-medicated.
- •Allergy to Aspirin.
- •Allergy to Clopidogrel, Ticagrelor and Prasugrel.
- •Allergy to any component of the drug eluting stent that is planned for use.
- •Patient has any other severe comorbidity that is felt to preclude enrolment by the investigator.
- •Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrolment).
结局指标
主要结局
Primary effectiveness endpoint 1
时间窗: Time of procedure
Mean MSA (mm2) by segment for segments with obstructive disease and ≥ 270 degrees calcification.
Primary safety endpoint
时间窗: 30 days
Incidence of Major Adverse Cardiac Events (MACE) at 30 days MACE consists of cardiac death, myocardial infarction and target vessel revascularisation
Primary effectiveness endpoint 2
时间窗: Time of procedure
Incidence of residual area stenosis \<50% by segment for segments with obstructive disease and ≥ 270 degrees calcification.
次要结局
- Canadian Cardiovascular Society (CCS) angina status at 12 months(12 months)
- Target vessel failure (TVF) at 12 months(12 months)
- Stent symmetry ratio for segments with obstructive disease and ≥ 270 degrees calcification(Time of procedure)
- MSA (mm2) for all segments.(Time of procedure)
- Stent symmetry ratio for all segments.(Time of procedure)
- Stroke at 12 months(12 months)
- All-cause mortality(12 months)
- Ischaemic-driven revascularisation(12 months)
- Minimum stent diameter (MSD) (mm) for segments with obstructive disease and ≥ 270 degrees calcification(Time of procedure)
- Stent expansion index (%) for segments with obstructive disease and ≥ 270 degrees calcification(Time of procedure)
- Stent expansion (%) for all segments.(Time of procedure)
- Device crossing success(Time of procedure)
- Individual components of MACE at 12 months(12 months)
- Stroke at 30 days(30 days)
- Target lesion failure (TLF) at 30 days(30 days)
- Peri-procedural myocardial infarction(48 hours)
- Spontaneous myocardial infarction(12 months)
- All revascularisation(12 months)
- Angiographic success(Time of procedure)
- MACE at 12 months(12 months)
- MSD (mm) for all segments.(Time of procedure)
- Procedural success(Time of procedure)
- Serious angiographic complications(24-48 hours)
- Individual components of MACE at 30 days(30 days)
- Canadian Cardiovascular Society (CCS) angina status at 30 days(30 days)
- Target lesion failure (TLF) at 12 months(12 months)
- Target vessel failure (TVF) at 30 days(30 days)
- Correlation between CK-MB and/or troponin levels post-PCI and outcomes at 30-days and 12 months(12 months)
- Angiographic and intracoronary imaging predictors of mechanical and procedural outcomes(12 months)
研究者
研究点 (6)
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