3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Freedom From Target Lesion Revascularization (TLR)
研究概览
简要总结
The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between December 1, 2016 and December 31, 2020 at the Clinique Rhône-Durance, Avignon, France
详细描述
This study is a non-interventional, retrospective, descriptive, single-centre study of adult male and female patients treated with Jetstream combined with Ranger for calcified femoropopliteal lesions, in order to assess the long-term clinical effects of this treatment.
The study will be conducted at the Clinique Rhône-Durance. Data on the management of all adult patients with calcified femoropopliteal lesions treated with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020 will be collected and recorded for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •treated for femoropopliteal lesions with Jetstream atherectomy in combination with a Ranger paclitaxel-eluting balloon (Drug Coated Balloon (DCB)) between 1 December 2016 and 31 December
- •Informed and not opposed to the use of their data in this study.
排除标准
- 未提供
研究组 & 干预措施
Patients with calcified femoropopliteal lesions
Patients presenting calcified femoropopliteal lesions (de novo, unique or multiple, mono or bilateral) and treated by atherectomy with Jetstream combined with Ranger between 1 December 2016 and 31 December 2020
干预措施: atherectomy (Device)
结局指标
主要结局
Freedom From Target Lesion Revascularization (TLR)
时间窗: From the date of the procedure until the date of the Target Lesion Revascularization, assessed at 1, 6, 12, 24, and 36 months post-procedure.
Kaplan-Meier estimates of the percentage of lesions free from clinically driven Target Lesion Revascularization (TLR) at each specified time point. The analysis was performed on the lesion population.
Evaluation of the Long-term Clinical Effects (After 3 Years of Follow-up) of Jetstream Atherectomy Combined With Ranger - Lesions Number and Proportion
时间窗: 3 years after the procedure
This primary endpoint measured the number and proportion of lesions with freedom from clinically-driven Target Lesion Revascularization (TLR) at 3 years of follow-up after the index procedure. This analysis was performed on the lesion population, and the frequency (number and percentage) of lesions achieving freedom from TLR were presented.
次要结局
- Evaluation of the 3-year Clinical Outcome of Jetstream Atherectomy Combined With Ranger, Without Reoperation, in Patients With Calcified Femoropopliteal Lesions(3 years following the procedure)
- Number of Participants With Acute Procedural Success(During the procedure (approximately 1 hour))
- Evaluation of the Success of the Jetstream Atherectomy Device Combined With Ranger in Patients With Calcified Femoropopliteal Lesions With Absence of Dissection, Vessel Rupture, Distal Embolization and Arteriovenous Fistula(During the procedure)
- Evaluation of the Success of the Jetstream Atherectomy Device Combined With Ranger in Patients With Calcified Femoropopliteal Lesions Defined as Absence of Dissection, Ruptured Vessels, Distal Embolization and Arteriovenous Fistula(During the procedure)
- Number of Lesions With Distal Embolisation(During the procedure (approximately 1 hour))
- Number of Lesions With Arteriovenous (AV) Fistula(During the procedure (approximately 1 hour))
- Primary Patency(At 12 and 36 months)
- Number of Participants With Bailout Stenting(During the procedure)
- Description of the Atherectomy Procedure in Patients With Calcified Femoropopliteal Lesions - Paclitaxel Eluting Balloons(During the procedure)
- Number of Participants Without Clinically-Driven Target Lesion Revascularization (TLR)(At 1, 6, 12, and 24, and 36 months post-procedure (Note: While the study followed patients for 36 months, the protocol explicitly listed 1, 6, 12, and 24 months for this specific secondary TLR outcome.))
- Number of Participants With Target Vessel Revascularization (TVR)(At 1, 6, 12, 24, and 36 months post-procedure)
- Number of Participants With Improvement in Rutherford Category(At 1, 6, 12, 24, and 36 months post-procedure)
- Number of Participants With Improvement in Systolic Pressure Index (SPI)(At 1, 6, 12, 24 and 36 months post-procedure)
- Number of Participants With All-Cause Mortality(3 years following the procedure)
- Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Deaths (Cardiovascular Death)(3 years following the procedure)
- Description of the 3-year Clinical Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions - Amputations(At 1, 6, 12, 24 and 36 months post-procedure)
- Number of Participants With Major Adverse Cardiovascular Events (MACE)(At 1, 6, 12, 24 and 36 months post-procedure)
- Number of Participants With Repeat Surgery(3 years following the procedure)