Status:
TERMINATED
COBRA SHIELD OCT Study
Lead Sponsor:
CeloNova BioSciences, Inc.
Collaborating Sponsors:
ClinLogix. LLC
Conditions:
Stable Angina
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography (OCT) at 3 month...
Detailed Description
Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography (OCT) at 3 month...
Eligibility Criteria
Inclusion
- Patient \>= 18 years old.
- Eligible for percutaneous coronary intervention (PCI).
- Patient provides written informed consent.
- Patient is willing to comply with follow-up evaluation.
- Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Stable angina pectoris or a positive functional ischemia study.
- Male or non-pregnant female patient
- Patient indicated for elective stenting of up to 2 stenotic lesions in two separate native coronary arteries.
- Reference vessel \>=2.5 mm and\<= 4.0 mm in diameter by visual estimate.
- Target lesion \<=20 mm in length by visual estimate.
- Protected left main lesion with \>50% stenosis.
- Target lesion stenosis \>= 70% and \< 100% by visual estimate OR Target lesion stenosis \<70% who meet physiological criteria for revascularization (i.e. positive Fractional Flow Reserve).
Exclusion
- Currently enrolled in another investigational device or drug trial.
- Previously enrolled in another stent trial within the prior 2 years.
- ANY planned elective surgery or percutaneous intervention within the subsequent 3 months.
- A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
- The patient requires staged procedure of either the target or any non-target vessel before OCT procedure at 3 months post-procedure.
- The target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement.
- Previous drug eluting stent (DES) or bare metal stent (BMS) deployment anywhere in the target vessel.
- Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Documented left ventricular ejection fraction (LVEF) \< 50% at the most recent evaluation.
- Patients with diagnosis of myocardial infarction (MI) within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment.
- Previous intervention in the target vessel.
- History of cerebrovascular accident or transient ischemic attack in the last 6 months.
- Leukopenia (leukocytes \< 3.5 x10\^9 / liter).
- Neutropenia (Absolute Neutrophil Count \< 1000/mm3) \<= 3 days prior to enrollment.
- Thrombocytopenia (platelets \< 100,000/mm3) pre-procedure.
- Active peptic ulcer or active GI bleeding.
- History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Serum creatinine level \> 2.0 mg/dl within 7 days prior to index procedure.
- Patients not responsive to Plavix/ aspirin and or unable to tolerate Plavix/ aspirin for 6 month post procedure.
- Patient on or may require anticoagulation therapy within 3 months of index procedure.
- Flow limiting dissections observed on OCT
- Significant tissue prolapse within the stent observed on OCT
- Unprotected left main coronary artery disease
- Target vessel with any lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line quantitative coronary arteriography (QCA).
- Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying \> 50% of the true lumen diameter) at any time.
- Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
- Target lesion with side branches \> 2.0mm in diameter.
- Target vessel is excessively tortuous (two bends \> 90˚ to reach the target lesion).
- Target lesion is severely calcified.
- Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1
- Target lesion is in a bypass graft
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02224235
Start Date
June 1 2014
End Date
June 1 2015
Last Update
October 6 2020
Active Locations (2)
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1
Satakunta Central Hospital
Pori, Finland, 28500
2
Heart Center, Turku University Hospital
Turku, Finland, 20520