Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- angiographic late lumen loss
研究概览
简要总结
The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
详细描述
Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.
Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=52 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 25 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.
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 (Outcomes Assessor)
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
- •Clinical evidence of stable or unstable angina or a positive functional study
- •Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no 'staged' procedures involving non-target lesions)
- •Diameter stenosis > 70% (visual estimate)
- •Stented segment length < 25 mm
- •Vessel diameter => 2.5 mm
- •Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
- •Signed patient informed consent form
- •Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol
排除标准
- •Left ventricular ejection fraction of < 30%
- •Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion.
- •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated.
- •Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
- •Severe chronic renal insufficiency.
- •Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment.
- •Participating in another device or drug study within the last 6 months
结局指标
主要结局
angiographic late lumen loss
时间窗: 6 months
angiographic late lumen loss
次要结局
- binary restenosis rate(6 months)
- major adverse cardiac events(12 months)