Coronary Restenosis Clinical Trial
Official title:
Evaluation of Endothelial ProGenitor Cell Capture Sirolimus-Eluting Stent by Optical Coherence Tomography: the COMBO Stent 36-months Clinical End-point Extension Study (EGO-COMBO Clinical End-point Extension Study Beyond 36 Months)
In this study, the safety and efficacy of COMBO TM stent beyond 36 months are assessed, in particular the occurrence of late stent thrombosis and late loss catch-up (restenosis).
The Genous Stent (the EPC Capture R-stent, OrbusNeich Medical Inc., Fort Lauderdale, FL) is
commercially available and has been used extensively in standard coronary intervention in
the treatment of more than 200 patients with critical coronary stenoses at Queen Mary
Hospital. The COMBO Stent (OrbusNeich Medical Inc., Fort Lauderdale, FL) is an improved
version of the Genous Stent and is now widely available for clinical use in all Hong Kong
hospitals. To date, more than 300 patients in Queen Mary Hospital have received the COMBO
stent as treatment for their coronary artery disease, and all of them remained stable
clinically.
The Genous Stent is a bio-engineered 316L stainless steel coronary stent with a
biocompatible coating having specific CD34 antibody on the inner surface. CD34 is a surface
antigen present on circulating endothelial progenitor cell (EPC). It will be bonded to the
CD34 antibody, resulting in capturing of the EPC onto the stent surface and differentiation
into endothelial layer. Animal model has demonstrated that a functional endothelial layer
could be formed as soon as 24 to 48 hours after Genous stent implantation (1). The
HEALING-FIM registry has shown that Genous stent is clinically safe and effective in the
treatment of coronary stenosis (2). Recent reports have further confirmed its efficacy in
patients with acute coronary syndrome requiring urgent revascularization (3,4).
The COMBO Stent is an improved version of the Genous Stent. The stent delivers a drug called
sirolimus to the treated coronary blood vessel. This stent also incorporates a CD34 antibody
coating that is designed to promote the healing of the treated coronary artery by catching
endothelial progenitor cells from circulating blood as they pass through the stent. These
cells are pro-healing and will help the blood vessel wall to heal over the stent more
quickly and restore normal tissue function in the stented area. The combination of these two
technologies in this new Combo stent is expected to produce even better clinical results,
which are published in the REMEDEE Study.
Pre-clinical animal study has already shown the Combo Stent promoted endothelialization and
reduced neointima formation, as assessed by both optical coherence tomography (OCT) and
histopathology (5). However, such beneficial endothelial coverage as assessed by OCT has
never been documented in human subjects, and has been addressed by previous study protocol:
the EGO Study (IRB: UW 10-256), EGO-COMBO Pilot Study (UW 10-342) and EGO-COMBO angiographic
extension study (UW 12-472). Queen Mary Hospital is currently the single cardiac centre
worldwide with such vast experience in using the COMBO stent for percutaneous coronary
intervention, together with intracoronary OCT to profile the stent's healing progress and
subsequent neo-intimal growth and behaviour.
This current study protocol serves as an extension study to evaluate the long term clinical
safety and efficacy of COMBO stent beyond 36 months post-implantation.
This is a single centre observational study to assess the safety and effectiveness clinical
endpoints of COMBO TM stent beyond 36 months. Clinical notes for all subjects that
previously participated in EGO-COMBO Pilot Study (UW 10-342) will be reviewed for clinical
end points according to the definition of Academic Research Consortium and angina symptoms
will be classified with Canadian Cardiovascular Society Angina Classification.
;
Observational Model: Cohort, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Completed |
NCT00248066 -
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
|
Phase 2 | |
Completed |
NCT00148356 -
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT02508714 -
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
|
N/A | |
Completed |
NCT01274234 -
OCT Evaluation of Healing of COMBO Stent
|
Phase 1/Phase 2 | |
Completed |
NCT01205789 -
EXCEL Clinical Trial (Universal Registry)
|
N/A | |
Recruiting |
NCT00426049 -
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
|
Phase 3 | |
Terminated |
NCT00243308 -
Serp-1 for the Treatment of Acute Coronary Syndrome
|
Phase 2 | |
Completed |
NCT00180466 -
PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
|
N/A | |
Completed |
NCT00859183 -
Oral Sirolimus for In-Stent Restenosis
|
Phase 4 | |
Completed |
NCT03667313 -
Treatment of In-Stent Restenosis 2 Study
|
Phase 3 | |
Recruiting |
NCT05089864 -
STAR and Deferred Stenting Study
|
N/A | |
Active, not recruiting |
NCT02175706 -
DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity
|
N/A | |
Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|
||
Completed |
NCT01331707 -
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
|
Phase 4 | |
Recruiting |
NCT00500279 -
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
|
Phase 4 | |
Completed |
NCT00402272 -
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
|
Phase 4 | |
Completed |
NCT01171820 -
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
|
Phase 4 | |
Recruiting |
NCT06075602 -
COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease
|