Coronary Restenosis Clinical Trial
— EGO-COMBOOfficial title:
Evaluation of Neointimal Healing of Endothelial Progenitor Cell Capturing Sirolimus-Eluting (COMBO) Stent by Optical Coherence Tomography: the EGO-COMBO Pilot Study
Verified date | February 2013 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Ethics Committee |
Study type | Interventional |
All subjects requiring percutaneous coronary intervention (PCI) and stenting are eligible to participate in the study. Restudy coronary angiogram with Optical Coherence Tomography (OCT) would be performed between 1 to 5 months at the time of a staged PCI procedure (for remaining coronary disease) or as clinically indicated, and then at 9 months. At the time of the 9-month restudy (a proper time window for drug eluting stent to develop into restenosis should it occur), any new disease detected or restenosis will be treated. The reported incidence of drug eluting stent restenosis is around 10% in simple lesions and is expected to be higher in diabetic patients, long lesions and multi-vessel diseases; a restudy at 9 months actually confers better protection to the patients with advanced disease and any restenosis can be treated timely. All data on clinical events and progress will be monitored and regular follow-ups will be carried out.
Status | Completed |
Enrollment | 61 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - patient aged 18-85 years old, - patient with coronary stenosis requiring percutaneous coronary intervention without contraindications to implantation of drug eluting stents - patient who consents to receive follow-up coronary angiogram and OCT examination. Exclusion Criteria: - patient who refuses to consent to follow-up coronary angiogram or OCT examination. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Division of Cardiology, Queen Mary Hospital, The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Prof. Stephen Lee |
Hong Kong,
Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothe — View Citation
Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-ter — View Citation
Granada JF, Inami S, Aboodi MS, Tellez A, Milewski K, Wallace-Bradley D, Parker S, Rowland S, Nakazawa G, Vorpahl M, Kolodgie FD, Kaluza GL, Leon MB, Virmani R. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abl — View Citation
Miglionico M, Patti G, D'Ambrosio A, Di Sciascio G. Percutaneous coronary intervention utilizing a new endothelial progenitor cells antibody-coated stent: a prospective single-center registry in high-risk patients. Catheter Cardiovasc Interv. 2008 Apr 1;7 — View Citation
Prati F, Cera M, Ramazzotti V, Imola F, Giudice R, Albertucci M. Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios. EuroInterve — View Citation
Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary end-point: OCT findings on percentage stent strut coverage in the 2nd to the 5th months (4 monthly groups). | Primary end-point: OCT findings on percentage stent strut coverage, malapposition, and neointimal thickness in the 2nd to the 5th months (4 monthly groups). | On 2nd, 3rd, 4th, and 5th months | No |
Secondary | OCT findings on late loss (neointimal thickness and neointimal area) at 9 months restudy. | OCT findings on late loss (neointimal thickness, neointimal area, percentage plaque volume, lumen area, and late loss in lumen area) at 9 months restudy. | 9 months | No |
Secondary | Major Adverse Cardiac Events | 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. |
Initial OCT follow up, 9 months follow up and one year follow up | No |
Secondary | Major Adverse Cardiac Events | 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. | Initial OCT follow up, 9 months OCT follow up and one year follow up | No |
Secondary | Any Stent Thrombosis according the Academic Research Consortium | Initial OCT follow up, 9 months OCT follow up and one year follow up | No | |
Secondary | Stroke | 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. | Initial OCT follow up, 9 months OCT follow up and one year follow up | No |
Secondary | Bleeding complication | 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. | Initial OCT follow up, 9 months OCT follow up and one year follow up | No |
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