EUCTR2014-004649-28-NL进行中（未招募）不适用
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. The TOSCA-5 Study (Total Occlusion Study in Coronary Arteries-5) - CTO-201 or TOSCA-5 Study
Matrizyme Pharma Corporation0 个研究点目标入组 110 人开始时间: 2015年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Screening Inclusion Criteria
- •A patient will be eligible for the study if s/he meets all of the following criteria:
- •1.Patient has provided signed and dated informed consent in accordance with required regulations.
- •2.Patient is male or female and greater than or equal to 18 years of age.
- •3.If patient is a female of childbearing potential, patient is willing to utilize contraception from Screening through the duration of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to Screening), intra-uterine device (IUD), Depo-Provera®, Norplant® System Implants, surgical sterilization (bilateral tubal ligation, hysterectomy, partner vasectomy), condom or diaphragm or cervical cap plus either contraceptive sponge, foam or jelly. For the purpose of this Study, women of non-childbearing potential are:
- •a.Females, regardless of age, with functioning ovaries who have a current documented tubal ligation, or who are surgically sterile (i.e. documented total hysterectomy or bilateral oophorectomy) or
- •b. Females 45 years of age who are post-menopausal for greater than 1 year (i.e. last menstrual period > 1 year) at Screening.
- •4.Patient is willing and able to comply with the protocol requirements during the study and be willing to refrain from any other elective cardiac revascularization procedures for the duration of study participation, unless medically necessary.
- •5.The patient 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.
- •6.Target CTO must be = 3 calendar months old by either:
- •a. Proven Chronicity: Angiographic documentation (conventional or coronary) of the target CTO 3 or more calendar months prior to Screening or
- •b. Assumed Chronicity: Identification of the target occlusion has occurred in the setting of chronic ischemic heart disease, with no known or suspected acute coronary syndrome (ACS) within 3 months.
- •7.The patient is receiving a course of optimal anti-ischemic medical therapy (at least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy). Medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or calcium antagonist) where appropriate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •A patient who meets any of the following criteria will not be eligible for the study:
- •1.Patient has documented chest radiation exposure > 4.0 Gray within 8 weeks of Day 0 (not including any Day 0 procedures). In the absence of Gray dosimetry, patients with > 60 minutes fluoroscopy time within 8 weeks of Day 0 will be excluded.
- •2.Patient’s target vessel is a saphenous vein graft occlusion.
- •3.Patient’s target lesion includes an occluded coronary stent.
- •4.Patient had ACS < 4 weeks from Screening, attributable to any coronary vessel.
- •5.Patient had ACS from 4 weeks to 3 calendar months prior to Screening, attributable to the target CTO. NOTE: If ACS is attributable to a different CTO the patient may still qualify.
- •6.Patient has known sensitivity to collagenase.
- •7.Patient has prior injected collagenase and/or any intra-coronary administration of collagenase.
- •8.Patient was treated in study CTO-1.
- •9.Patient has a known sensitivity to contrast dye.
- •10.Patient has estimated glomerular filtration rate (GFR) is < 30 mL/min, as provided for in the clinical chemistry results available at/for Screening.
- •11.Patient has any medical condition, which in the judgment of the Investigator and/or Sponsor makes the patient a poor candidate for the investigational procedure.
- •12.Patient is a pregnant or lactating female (check at Screening and Day 0 before randomization).
- •13.Patient used any investigational or experimental drug or device within 30 days of Screening.
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