Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Minimum Stent Area After Percutaneous Coronary Intervention
研究概览
简要总结
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
详细描述
This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational atherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio.
The clinical investigation will be conducted at 2 centers in the US. Up to 48 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.
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
- 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
- •Adults Patients ≥18 years of age
- •Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography
- •Patients eligible for percutaneous coronary intervention
排除标准
- •Patients in cardiogenic shock
- •Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period
- •Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
- •Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception
- •Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months
- •Currently participating in another investigational drug or device study
- •Patients referred to coronary artery bypass grafting after heart team discussion
- •Angiographic Specific Exclusion Criteria:
- •Lesion(s) with angulation > 45 degrees by visual estimate
- •Lesion(s) stenosis through which a guidewire will not pass.
- •Last remaining vessel with compromised (<30%) left ventricular function
- •Saphenous vein grafts
- •Angiographic evidence of thrombus
- •Angiographic evidence of significant dissection at the treatment site
- •Lesion(s) with previously placed stent within 10 mm (visual estimate)
研究组 & 干预措施
rotational atherectomy + cutting balloon
angioplasty with rotational atherectomy followed by cutting balloon
干预措施: rotational atherectomy (Procedure)
rotational atherectomy + cutting balloon
angioplasty with rotational atherectomy followed by cutting balloon
干预措施: cutting balloon (Device)
rotational atherectomy + plain old balloon
angioplasty with rotational atherectomy followed by plain old balloon
干预措施: rotational atherectomy (Procedure)
rotational atherectomy + plain old balloon
angioplasty with rotational atherectomy followed by plain old balloon
干预措施: plain old balloon (Device)
结局指标
主要结局
Minimum Stent Area After Percutaneous Coronary Intervention
时间窗: Post-procedure, Day 0
Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)
次要结局
- Number of Participants With Dissection After Percutaneous Coronary Intervention(Post-procedure, Day 0)
- Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography(Post-procedure, Day 0)
- Percent Residual Diameter Stenosis In-stent After Stent Implantation(Post-procedure, Day 0)
- In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation(Post-procedure, Day 0)
- Minimum Percent Stent Expansion After Percutaneous Coronary Intervention(Post-procedure, Day 0)
- Mean Percent Stent Expansion After Percutaneous Coronary Intervention(Post-procedure, Day 0)
- Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon(Post-Procedure, Day 0)
- Number of Participants With Difficulty in Withdrawing/Advancing the Device(Post-Procedure, Day 0)
- Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention(30 days)
- Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention(Post-Procedure, Day 0)
- Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)(Post-CBA/NCBA before stent, Day 0)
- Percent Residual Diameter Stenosis In-segment After Stent Implantation(Post-procedure, Day 0)
- Minimum Lumen Diameter In-segment After Stent Implantation(Post-procedure, Day 0)
- Number of Participants With Side Branch Closure After Stent Implantation(Post-procedure, Day 0)
- Number of Participants With a Balloon Rupture(Post-Procedure, Day 0)
- Number of Participants With Blade Detachment(Post-Procedure, Day 0)
- Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention(30 days)
- Number of Participants With Vascular Complications After Percutaneous Coronary Intervention(30 days)
- Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography(Post-procedure, Day 0)
- Minimum Lumen Diameter In-stent After Stent Implantation(Post-procedure, Day 0)
- Number of Participants With Dissection Type B or Greater(Post-CBA/NCBA before stent and after stent, Day 0)
- Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation(Post-procedure, Day 0)
- Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention(30 days)
- Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention(30 days)
- Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention(30 days)
- Angina Status According to Canadian Cardiovascular Society (CSS) Classification(270 days)
- Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention(30 days)
- Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention(30 days)
- Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention(30 days)
- Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention(30 days)
研究者
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Professor of Medicine/Cardiology
Icahn School of Medicine at Mount Sinai