Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 7
- 主要终点
- Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
研究概览
简要总结
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.
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
- •Subject's age ≥ 18 years
- •Rutherford Clinical Category 3 - 5
- •Lesions [except in-stent restenosis (ISR)] of the distal popliteal (POP segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (DS) by angiography
- •Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- [Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care]
- •Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length
- •Target lesion length up to 20 cm
排除标准
- •Subject or subject's legal representative is not willing to sign an Ethics Committee approved informed consent form or comply with the study protocol requirements
- •Contraindicated by either device, per Instructions For Use
- •Presence of inflow lesion (≥ 50 % DS) or inflow not successfully treated (≥ 50% DS and/or unresolved significant angiographic complication)
- •Compromised outflow distal to the target lesion (≥ 70 % DS) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space
- •Subject has more than 2 target vessels requiring treatment
- •The guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen
- •Presence of significant (≥ 70 % DS) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % DS and/or significant angiographic complication)
- •Subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb
- •Creatinine > 2.5 mg/dL, unless on dialysis
- •Subject has any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study
- •Subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures
- •Subject is pregnant or planning to become pregnant within the study period
- •Subject has an unresolved severe systemic infection
- •Subject has an anticipated life span of less than one year
- •Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds
- •Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy
- •Pre-dilatation of the target lesion prior to randomization and OA treatment
结局指标
主要结局
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
时间窗: Baseline, 6 months and 12 months post-procedure
Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss. The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure.
Device Success
时间窗: During the procedure
Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used.
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure
时间窗: 6 months and 12 months post-procedure
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months.
Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure
时间窗: 6 months and 12 months post-procedure
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months.
Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure
时间窗: 6 months and 12 months post-procedure
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure.
Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure
时间窗: 6 months and 12 months post-procedure
Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as \<50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory.
次要结局
未报告次要终点