Multivessel Coronary Artery Disease Clinical Trial
Official title:
Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI
NCT number | NCT01947439 |
Other study ID # | BATTLE IN MULTI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | June 2021 |
Verified date | August 2021 |
Source | Keimyung University Dongsan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent. Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated. Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics. However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments. The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.
Status | Completed |
Enrollment | 932 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients who need multi-vessel stenting with multi-vessel disease - patients with signed informed consent Exclusion Criteria: - known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group - Cardiogenic shock - Pregnant women or women with potential childbearing - End-stage diseases with life expectancy shorter than 2 years - patients with other Drug eluting stents implanted - Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kosin University Hospital | Busan | |
Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
Korea, Republic of | Daegu Fatima Hospital | Daegu | |
Korea, Republic of | KyungPook National University Hospital | Daegu | |
Korea, Republic of | Yeungnam University Hospital | Daegu | |
Korea, Republic of | Inje University Ilsan Paik Hospital | Ilsan | Kyeongki |
Korea, Republic of | Chonnam National University Hospital | Kwangju | Chonnam |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Ulsan University Hospital | Ulsan | Gyeongbuk |
Lead Sponsor | Collaborator |
---|---|
Keimyung University Dongsan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year composite end points | All cause death, non fatal myocardial infarction, any revascularization | up to 2 years | |
Secondary | All cause death | All cause death | up to 2 years | |
Secondary | non-cardiac death | non-cardiac death | up to 2 years | |
Secondary | cardiac death | cardiac death | up to 2 years | |
Secondary | non fatal myocardial infarction | non fatal myocardial infarction | up to 2 years | |
Secondary | Any revascularization | Any revascularization | up to 2 years | |
Secondary | Target lesion revascularization | Target lesion revascularization | up to 2 years | |
Secondary | Target vessel revascularization | Target vessel revascularization | up to 2 years | |
Secondary | stent thrombosis | stent thrombosis | up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05669222 -
The FAVOR V AMI Trial
|
N/A | |
Not yet recruiting |
NCT06025071 -
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
|
Phase 4 | |
Recruiting |
NCT05786131 -
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
|
N/A | |
Recruiting |
NCT06168305 -
Safety and Effectiveness of GENOSS DES in Patients With Multivessel Coronary Artery Disease
|
||
Not yet recruiting |
NCT05835167 -
Complete Revascularization Via Inferior Part-sternotomy
|
N/A | |
Completed |
NCT01881555 -
Functional Testing Underlying Coronary Revascularisation
|
N/A | |
Not yet recruiting |
NCT06400290 -
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
|
N/A | |
Active, not recruiting |
NCT01621438 -
Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
|
N/A | |
Not yet recruiting |
NCT06378775 -
Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery
|
N/A | |
Completed |
NCT05125367 -
Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease
|
||
Recruiting |
NCT05333068 -
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
|
N/A | |
Withdrawn |
NCT03851276 -
A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT.
|
Phase 4 | |
Completed |
NCT02813473 -
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
|
||
Recruiting |
NCT05698719 -
Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients
|
||
Completed |
NCT01399736 -
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
|
N/A | |
Not yet recruiting |
NCT01311323 -
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
|
N/A | |
Completed |
NCT00818792 -
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease
|
Phase 2 | |
Completed |
NCT01199419 -
Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP
|
N/A | |
Completed |
NCT04743154 -
In-hospital Versus After-discharge Complete Revascularization
|
N/A | |
Terminated |
NCT02334826 -
Revascularization With BVS or CABG in Patients With Advanced CAD
|
Phase 4 |