CTRI/2019/05/018886尚未招募Unknown
A prospective, multicenter, open label, randomized controlled trial to evaluate safety and performance of Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter) versus Mozecâ„¢ PTA Balloon Catheter for treatment of blocked or narrowed below the knee arteries.
Meril Life Sciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2019年7月15日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Major adverse event [Time Frame: 6 months]
研究概览
简要总结
This is a prospective, multicenter, open label, randomized controlled trial to evaluate safety and performance of Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter) versus Mozecâ„¢ PTA Balloon Catheter for treatment of blocked or narrowed below the knee arteries in approximately 280 patients
The objective of the study is to compare safety and performance of Paximusâ„¢ with a Mozecâ„¢ PTA balloon for treatment of blocked or narrowed below the knee arteries and to evaluate in-human pharmacokinetics (PK) of the drug in Paximusâ„¢. All patients will be approached to sign Informed Consent Form approved by respective Ethics Committee before starting the study related process.
After screening for eligibility, patients found eligible for this study will be randomly assigned to either paclitaxel-based drug-eluting balloon (DEB) angioplasty or standard balloon angioplasty in 1:1 ratio using computer - generated randomization system.
30% of the patients will be considered for LLL analysis based on patients’ consent.
14 patients will be considered for PK analysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant female ≥18 to ≤80 years of age.
- •Patient or his/her legally acceptable representative (LAR) willing to provide informed consent and comply with the required study procedures and visits.
- •Patient agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure.
- •Female patient of childbearing potential who does not plan pregnancy for up to 2 years from the date of index procedure.
- •For a female patient of childbearing potential a pregnancy test must be performed with negative results at screening visit.
- •Clinically all patients must be in Rutherford category 2 to
- •One identifiable single solitary or a series of multiple adjacent lesions in the blocked or narrowed arteries below the knee due toPeripheral Artery Disease (PAD) defined as ≥70% diameter stenosis with length in the range of ≥20 mm to ≤150 mm.
- •If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study
- •Patients planned for PK analysis must agree to undergo PK follow-ups as per protocol.
排除标准
- •Patient with known hypersensitivity to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
- •Patient with known allergies or sensitivity to paclitaxel.
- •Patient having gastrointestinal bleeding or coagulopathy.
- •Patient having target lesion that the investigator is unable to cross by a guide wire.
- •Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper of the delivery system.
- •Patient is probable case of stenting for the target lesion during the screening as per adjudication of investigator.
- •Patient with severe renal insufficiency (serum creatinine >2.0 mg/dL).
- •Untreated ipsilateral iliac artery.
- •Acute aneurysm in target the target vessel.
- •Patient participating in another device or drug study at the time of consenting process.
- •Major surgical procedures (viz.
- •major invasive procedures or endovascular interventions for peripheral artery disease etc.
- •or surgeries that might impact safety of participating patients as per discretion of investigator) within 30 days prior to this study or planned within 2 years after entry into this study.
- •Patient with life expectancy less than 2 years.
- •Adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon etc) within 30 days prior to this study or planned within 30 days of entry into this study.
- •Patient who required bailout stenting.
- •Diagnosed with cancer or malignancy
- •Any medical condition, which in investigator’s opinion, may interfere with patient’s participation in the study.
结局指标
主要结局
Major adverse event [Time Frame: 6 months]
时间窗: 6 Months
- Major adverse event is defined as all-cause death, target limb amputation and clinically driven target lesion revascularization (CD-TLR)
时间窗: 6 Months
次要结局
- Primary Patency(At post-procedure and after 6 months)
- Late Lumen Loss(At post-procedure and after 6 months)
- All cause of death(At Post-procedure, 1 month, 6 months , 12 months and 24 months)
- Clinically driven TLR (CD-TLR)(At Post-procedure, 1 month, 6 months , 12 months and 24 months)
- Target limb amputation(At Post-procedure, 1 month, 6 months , 12 months and 24 months)
- Change of Ankle-Brachial index (ABI)(At Baseline, Post-procedure, 1 month, 6 months , 12 months and 24 months)
- Walking Impairment Questionnaire (WIQ)(At 1 month, 6 months, 12 months and 24 months)
- Change in Rutherford Classification(At Baseline, Post-procedure, 1 month, 6 months, 12 months and 24 months)
- Device Success(During index procedure)
- Procedural Success(At Post-procedure)
- User Rating on Technical Properties(At index procedure)
研究者
研究点 (1)
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