Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT01271335
Eligibility Criteria:
Inclusion Criteria:
Candidates for this study must meet ALL of the following inclusion criteria:
* Subject is willing and able to provide an informed consent
* Subject is willing and able to comply with the study procedures and follow-up
* Subject is 35 years of age or older
* Women who are non-reproductive, or reproductive women who are willing and able to practice effective birth control methods. A urine pregnancy test should be done at the screening/Day0 on all reproductive women of child bearing ability
* Subjects with CTO (older than 6 weeks or unknown duration based on the investigator's assessment of appropriateness for the study) with a clinical indication for revascularization. In subjects with occlusions of unknown duration, there must be absence of any identifiable ischemic event in the 6 weeks prior to enrolment in the study
* At least 1 previously failed attempt to cross the CTO
* Absence of pericardial effusion on 2D Echocardiogram
Exclusion Criteria:
Candidates for this study who meet any of the following criteria at the time of the screening visit are NOT eligible to be enrolled in this study:
* Culprit vessel is a saphenous vein graft occlusion
* True ostial LAD, LCX or RCA occlusions (since collagenase delivery will be unreliable)
* Presence of moderate or large pericardial effusion on echocardiogram within 2 weeks of the procedure
* Major side branch (1.5 mm diameter) within 3 mm proximal to the occlusion. (This is to prevent the infusate being diverted through a side branch and to prevent ischemia during the prolonged period of time during the infusion)
* Renal dysfunction (creatinine greater than 2 x ULN)
* Severe calcification (collagenase can not degrade calcium) based on consensus of 2 interventional cardiologists after review of coronary angiogram.
* Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Subject is a pregnant or lactating female (women of childbearing potential must have a negative serum beta-HCG within 24 hours prior to the inclusion)
* Subject is or has been partaking in another investigational product clinical study within 30 days of Screening/Day0
* Subjects with bleeding abnormalities (e.g. Factor VIII deficiency) and /or subjects that have experienced any medically documented active site of bleeding within 30 days of the screening visit, such as, but not limited to, the gastrointestinal or genitourinary tract or intercerebral hemorrhage.
* Subjects with recent acute coronary syndrome (ACS) (\< 4 weeks). For those patients who had ACS ≥ 4weeks ago, only the non-culprit vessel from the recent ACS can be considered eligible for this study if all other inclusion and exclusion criteria have been met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01271335
Study Brief:
Protocol Section:
NCT01271335