NCT01753180已完成2 期
A 2-stage Study to Evaluate Single Doses of MZ-004 at Different Dose Levels in Patients With Chronic Total Occlusions. Stage 1: Open Label Training Stage. Stage 2: Double-blind, Randomized, Placebo-Controlled Stage
Matrizyme Pharma Corporation13 个研究点 分布在 3 个国家目标入组 76 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Anterograde PCI success rate for patients with a target CTO
研究概览
简要总结
A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study, evaluating acute intra-coronary injected collagenase prior to routine standard-of-care percutaneous revascularization procedures in subjects with chronic total coronary artery occlusions (CTOs).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females patients > 18 years of age who has a clinically driven, planned PCI of the target CTO, in a major epicardial coronary artery, without planned revascularization of other coronary stenosis/stenoses in major epicardial segments.
- •Target CTO must be greater than or equal to 3 calendar months prior to Screening
- •Target CTO must meet protocol defined criteria for entry
- •Patient is receiving a course of optimal anti-ischemic medical therapy (at least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy)
排除标准
- •Documented chest radiation exposure > 4.0 Gray within 8 weeks of Day 0
- •Target vessel is not an occluded stent, saphenous vein graft
- •Patient had ACS < 4 weeks from Screening, attributable to any coronary vessel
- •Patient has non-healed dissection plane extending to a point adjacent to the coronary lumen distal to the target CTO
- •Patient has a known or suspected target vessel perforation within 30 days of Day 0
- •Angiographic exclusion criteria as defined in the protocol
研究组 & 干预措施
collagenase
Experimental
干预措施: collagenase (Biological)
saline
Placebo Comparator
干预措施: saline (Drug)
结局指标
主要结局
Anterograde PCI success rate for patients with a target CTO
时间窗: Day 1 of study procedures
To assess the PCI success rates in CTOs that have failed a previous PCI attempt between different doses of MZ-004 and placebo
次要结局
- Total fluoroscopy time(Day 0 and Day 1 of study procedures)
- Total PCI procedural time(Day 1 of study procedures)
- Soft wire crossing(Day 1 study procedures)
- Safety(Day 0, Day 1 and Day 2 of study procedures)
研究者
研究点 (13)
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