NCT03913832进行中（未招募）不适用
Magic Touch Sirolimus Coated Balloon (Concept Medical) Versus SeQuent Pease Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Small Vessels
Concept Medicals BV9 个研究点 分布在 3 个国家目标入组 121 人开始时间: 2020年8月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 121
- 试验地点
- 9
- 主要终点
- Net Gain (mm) In-segment
研究概览
简要总结
The study is a prospective, multinational (Italy, Ireland and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated balloon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in small vessels (≤2.75 mm) with respect to Net Gain (mm) at 6 months follow-up
详细描述
A prospective, randomized, multi-centre study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.75mm). Vessel size will be determined first by QCA on-line (screening, pre-procedure). If, based on QCA on-line the vessel size pre-procedure is ≤2.75mm and following a successful pre-dilatation (i.e. no angiographic dissections type CDEF and TIMI>2), the subject will be randomized in a 1:1 fashion to Magic Touch or SeQuent Please Neo. OCT will be performed post pre-dilatation (guidance) prior to drug coated balloon (DCB) treatment. The DCB balloon size will be selected based on OCT measurements.
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)
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
- •Male or female patients ≥18 years
- •Patient with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values
- •Note: For patients showing elevated Troponin (e.g. non-STEMI patients) at baseline (within 72h pre-PCI) an additional blood sample must be collected prior to randomization to confirm that:
- •hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped
- •CK-MB and CK levels are within normal range If hs-cTn or Troponin I or T levels are stable or have dropped, the CK-MB and CK levels are within normal ranges, and the ECG is normal, the patient may be included in the study.
- •The patient has a planned intervention in one or two separate major epicardial territories (LAD, LCX or RCA) and has at least one de-novo lesion in a small vessel (≤2.75mm by QCA prior to pre-dilatation)
- •Target lesion length ≤30 mm
- •Able to understand and provide informed consent and comply with all study procedures including 6 months angiographic follow-up
- •Patient must have completed the follow-up phase of any previous study
排除标准
- •Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- •Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
- •Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor
- •Patient suffered from stroke/TIA during the last 6 months
- •Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
- •Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment)
- •Patient undergoing planned surgery within 6 months with the necessity to stop DAPT
- •History of bleeding diathesis or coagulopathy
- •The patient is a recipient of a heart transplant
- •Concurrent medical condition with a life expectancy of less than 12 months
- •The patient is unwilling/not able to return for angiographic recatherisation at 6 month follow-up
- •Currently participating in another trial and not yet at its primary endpoint.
- •Angiographic exclusion criteria:
- •The patient has a planned intervention in three separate major epicardial territories (3 vessel disease)
- •The patient has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel disease)
- •Target vessel size >2.75 mm (by QCA)
- •Target vessel size <2.00 mm (by QCA)
- •Target lesion has a total occlusion or TIMI flow <2
- •Target lesion in left main stem
- •The target vessel contains visible thrombus
- •Aorto-ostial target lesion (within 3 mm of the aorta junction)
- •Moderate-severe tortuous, calcified or angulated coronary anatomy of the target vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- •Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft.
结局指标
主要结局
Net Gain (mm) In-segment
时间窗: 6 Months
The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.
次要结局
- Device success(Post procedure (Right after the treatment with drug coated balloon))
- Device oriented Composite Endpoint (DoCE / TLF): Cardiac death(1, 6 months and 12 Months)
- Procedure Success(Post procedure (Right after the treatment with drug coated balloon))
- Acute/subacute/early/late vessel closure/thrombosis(1, 6 months and 12 Months)
- Angiographic outcomes: late lumen loss(6 months)
- Angiographic outcomes:Minimal lumen diameter(6 months)
- Angiographic outcomes: Percent diameter stenosis(6 months)
- Angiographic outcomes: Restenosis rate(6 months)
- Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI)(1, 6 months and 12 Months)
- Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR)(1, 6 months and 12 Months)
研究者
研究点 (9)
Loading locations...
相似试验
招募中
不适用
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery LesionsIn-Stent RestenosisCardiovascular DiseasesCoronary Artery DiseaseNCT05908331Concept Medical Inc.492
招募中
不适用
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery StenosisPeripheral Artery DiseaseNCT04982367Acotec Scientific Co., Ltd166
进行中（未招募）
不适用
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM IICoronary Artery StenosisCoronary Artery DiseaseNCT04893291Fondazione Ricerca e Innovazione Cardiovascolare ETS1,820
已完成
不适用
The All-comers Sirolimus-coated Balloon European RegistryPercutaneous Coronary InterventionAngioplasty, Balloon, CoronaryCoronary Angioplasty, Transluminal BalloonArteriosclerosis, CoronaryNCT03085823Fatebenefratelli and Ophthalmic Hospital2,123
招募中
不适用
SPAGO: Sirolimus Paclitaxel Angiographic Gain ObjectiveStenosis CoronaryCoronary Artery LesionPercutaneous Coronary InterventionCoronary Artery DiseaseNCT06373601Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS140