Chocolate PTA Balloon Compared to Conventional Balloon Angioplasty for Sustained Lumen Gain in Below the Knee Arteries - CHOCO-CABANA Trial-
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 15
- 主要终点
- Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
研究概览
简要总结
The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon.
All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized.
In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.
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
Randomization per envelope
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
- •>18 years of age
- •Chronic stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries
- •Patients with clinical conditions requiring assessment of vessel patency of treated BTK lesion 6 months post procedure as part of clinical standard of care to prevent amputa-tions as consequence of non-detected re-stenosis
- •BTK intervention with lesions between 1 and 25 cm
- •Sufficient outflow of the treated artery to the foot (less than 50% stenosis or sufficient collaterals)
- •All BTK lesions either to be treated with conventional PTA or with the Chocolate PTA balloon (if inclusion criteria 4 and 5 apply)*
- •* The longest lesion will be taken as primary lesion. All other lesions will be also analyzed within the study protocol but separately evaluated. If a secondary lesion does not fulfill the inclusion criteria 4 and 5, the lesion can be treated upon the decision of the operator and will not be analyzed within the study protocol.
- •Rutherford 3-5 patients
- •Patients who are able to be followed to assess vessel patency according to standard lo-cal hospital care (e.g. DUS, MRA)
- •Successfully treated inflow lesions up to TASC B
排除标准
- •Acute or sub-acute thrombosis
- •In-stent restenosis
- •Rutherford 1-2 and 6
- •Patient who is not fit for follow-up (including contraindication for MRA)
- •Vessel preparation with cutting balloon, lithotripsie, atherectomy
结局指标
主要结局
Recoil (lumen loss > 30%) 15-30 min after study intervention angiographically documented and analyzed by a core-lab
时间窗: 15-30 min after study intervention
The minimal lumen of the artery in the area of Intervention in mm will be compared directly after the Intervention and at 15-30 minuntes
次要结局
- the loss of patency greater than 50% in the MRA after six month(6 month)
- the re-occlusion rate at 6 months (measured by MRA)(6 month)
- Residual stenosis (MLD post compared to RVD, % of RVD) >50% after the invention(immedetely after the intervention)
- Wound status at 1 and 6 months:(1 and 6 months)
- target lesion revascularization TLR rate at 1 and 6 months(1 and 6 months)
- Amputation rate at 1 and 6 months(1 and 6 months)
- Clinical presentation (Rutherford 0, 1, 2, 3, 4, 5 or 6 at 30 days and 6 months(1 and 6 month)
- Ancle brachial index (ABI) compared to baseline and post intervention and 6 months(directly after the intervention and 6 month)
- DUS vs. MRA at 6 months(6 month)
研究者
Prof. Dr. med. Gunnar Tepe
Chief Physician of the Radiology Department
Klinikum Rosenheim