OCT Evaluation of Healing of COMBO Stent (EGO-COMBO)
|Coronary Restenosis Coronary Thrombosis||Device: COMBO Stent (OrbusNeich Medical, Fort Lauderdale, Florida)||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Neointimal Healing of Endothelial Progenitor Cell Capturing Sirolimus-Eluting (COMBO) Stent by Optical Coherence Tomography: the EGO-COMBO Pilot Study|
- Primary end-point: OCT findings on percentage stent strut coverage in the 2nd to the 5th months (4 monthly groups). [ Time Frame: On 2nd, 3rd, 4th, and 5th months ]Primary end-point: OCT findings on percentage stent strut coverage, malapposition, and neointimal thickness in the 2nd to the 5th months (4 monthly groups).
- OCT findings on late loss (neointimal thickness and neointimal area) at 9 months restudy. [ Time Frame: 9 months ]OCT findings on late loss (neointimal thickness, neointimal area, percentage plaque volume, lumen area, and late loss in lumen area) at 9 months restudy.
- Major Adverse Cardiac Events [ Time Frame: Initial OCT follow up, 9 months follow up and one year follow up ]
Major Adverse Cardiac Events (MACE) which defined as:
- Death from all cause including cardiac death
- Any Myocardial Infarction (Q wave and non Q-wave)
Elevation of post-procedure CK levels to greater 2 times normal without new Q waves is considered a non Q-wave MI.
Development of new, pathological Q waves in 2 or more contiguous leads,as assessed by the investigator and confirmed by the Clinical Endpoint Committee and elevation of cardiac enzymes. In the absence of ECG data the CEC may adjudicate Q wave MI based on the clinical scenario and appropriate cardiac enzyme data.
- Major Adverse Cardiac Events [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]3. Target Lesion Revascularization requiring repeat PCI or CABG to the target lesion. Clinically driven Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis ≥50% by QCA, or revascularization of a target lesion with diameter stenosis ≥ 70% by QCA without either angina or a positive functional study.
- Any Stent Thrombosis according the Academic Research Consortium [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]
- Stroke [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]Stroke defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
- Bleeding complication [ Time Frame: Initial OCT follow up, 9 months OCT follow up and one year follow up ]Bleeding complication defined as a procedure related hemorrhagic event that requires a transfusion or surgical repair. These may include a hematoma requiring treatment of retroperitoneal bleed.
|Study Start Date:||October 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: COMBO Stent
Device: COMBO Stent (OrbusNeich Medical, Fort Lauderdale, Florida)
The COMBO Stent is a hybrid version of the GENOUS Stent. Upon implantation to the coronary artery, the stent will deliver a drug (sirolimus) to the wall of the treated segment to suppress neointimal growth, in addition to the anti-CD34 antibody coating which will in theory attract circulatory endothelial progenitor cells to hasten endothelialization and promote healing of the stented segment, and thereby may reduce late stent thrombosis.
Other Name: COMBO Stent
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01274234
|Division of Cardiology, Queen Mary Hospital, The University of Hong Kong|
|Hong Kong, Hong Kong|
|Principal Investigator:||Stephen Lee, MD FRCP FACC||Queen Mary Hospital, The Unversity of Hong Kong|