Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
概览
- 阶段
- 不适用
- 干预措施
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
- 疾病 / 适应症
- Chronic Limb-Threatening Ischemia
- 发起方
- R3 Vascular Inc.
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.
研究者
入排标准
入选标准
- •General Inclusion Criteria
- •Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Institutional Review Board / Ethics Committee.
- •Subject agrees not to participate in any other investigational device or drug study for a period of at least 12 months following the index procedure.
- •Note: Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.
- •Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or
- •Subject is ≥ 18 years of age.
- •Subject agrees to complete all protocol-required follow-up visits, including angiograms.
- •Angiographic Inclusion Criteria
- •Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels: tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery.
- •Target lesion(s) must be located in the proximal 2/3 of the native infrapopliteal vessels and at least 10 cm above the tibio-talar joint.
排除标准
- •Subjects must not meet any of the following general and angiographic exclusion criteria:
- •Subject with Body Mass Index (BMI) \<
- •Subject is pregnant or nursing. Subjects who plan pregnancy during the clinical investigation follow-up period may not be enrolled.
- •Note: Subjects of child-bearing potential must have a negative pregnancy test ≤ 28 days prior to the index procedure and agree to use contraception for 6 months.
- •Estimated life expectancy \<1 year, in the opinion of the Investigator at the time of enrollment.
- •Subject is permanently bedridden.
- •Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide), lactic acid, or platinum-iridium) or to study medications (including antiplatelet medications) or to contrast media and who cannot be adequately premedicated.
- •Subject has planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.
- •Subject has had revascularization procedure within the target vessel in the previous 3 months
- •Subject has prior major amputation (above or below the knee or above the ankle) involving the target limb.
研究组 & 干预措施
MAGNITUDE BRS
Participants who receive the MAGNITUDE BRS device will be included in this arm
干预措施: MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
Percutaneous Transluminal Angioplasty (PTA)
Participants who receive a PTA device will be included in this arm
干预措施: Percutaneous Transluminal Angioplasty (PTA)
结局指标
主要结局
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
时间窗: 6 months
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)
时间窗: POD at 30 Days and MALE at 6 months
Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and POD includes perioperative (30-day) mortality.