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)
Verified date | October 2014 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Department of Health |
Study type | Observational |
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).
Status | Completed |
Enrollment | 59 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient previously participated in EGO-COMBO Pilot Study (UW 10-342) Exclusion Criteria: - Patient not previously participated in EGO-COMBO Pilot Study (UW 10-342) |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
China | Department of Medicine, Queen Mary Hospital, The University of Hong Kong | Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
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
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardize — 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
Haude M, Lee SW, Worthley SG, Silber S, Verheye S, Erbs S, Rosli MA, Botelho R, Meredith I, Sim KH, Stella PR, Tan HC, Whitbourn R, Thambar S, Abizaid A, Koh TH, Den Heijer P, Parise H, Cristea E, Maehara A, Mehran R. The REMEDEE trial: a randomized compa — 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 | Composite Major Adverse Cardiac Events (MACE) | beyond 36 months | No | |
Secondary | All-cause mortality | beyond 36 months | No | |
Secondary | Myocardial infarction | beyond 36 months | No | |
Secondary | Target Lesion Revascularization | beyond 36 months | No | |
Secondary | Angina Class | beyond 36 months | No | |
Secondary | Target Vessel Failure | beyond 36 months | No | |
Secondary | Cardiac Death | beyond 36 months | No |
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 |
NCT01331707 -
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
|
Phase 4 | |
Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|
||
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
|