Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01621438
Other study ID # H-1203-087-402
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 7, 2012
Last updated August 24, 2017
Start date May 2012
Est. completion date September 2018

Study information

Verified date August 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.


Description:

Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed.

Pre-specified Subgroup Analysis

The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects:

- Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.).

- Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed).

- Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test.

- Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR <0.75, 0.75-0.80, and >0.80).

- Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1136
Est. completion date September 2018
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Subject must be at least 18 years of age.

- Subject must have stenosis (>30% by visual estimate) in all 3-epicardial coronary arteries.

- FFR should be measured at all 3-vessels at the end of a procedure.

Exclusion Criteria:

- Depressed left ventricular systolic function (ejection fraction < 35%)

- ST-elevation myocardial infarction within 72 hours,

- Prior coronary artery bypass graft surgery

- Creatinine level >= 2.0mg/dL or dependence on dialysis

- Abnormal final myocardial flow (TIMI flow < 3)

- Planned bypass surgery

- Failed FFR measurement

- Failed intended revascularization

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Fuwai hospital Beijing
China Guandong general hospital Guandong
China Queen Mary Hospital, The University of Hong Kong Hong Kong
China United Christian Hospital Hong Kong
China Nanjing 1st hospital Nanjing
China Zhejiang No 2 hospital Zhejiang
Japan Gifu heart center Gifu
Japan Kokura memorial hospital Kita-Kyushu
Japan 2nd Red Cross hospital Kyoto
Japan Aichi Medical university hospital Nagakute
Japan Tokyo medical college hospital Tokyo
Japan Wakayama medical university Wakayama
Korea, Republic of Keimyung University Dongsan medical center Daegu
Korea, Republic of Inje university Ilsan Paik hospital Ilsan
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital, Seoul, Korea Seoul
Korea, Republic of Ajou university hospital Suwon
Korea, Republic of Ulsan university hospital Ulsan
Singapore National University Heart center Singapore
Taiwan National Taiwan University hospital Taipei city

Sponsors (20)

Lead Sponsor Collaborator
Seoul National University Hospital Aichi Medical University, Ajou University School of Medicine, Fu Wai Hospital, Beijing, China, Gifu heart center, Japan, Guangdong General Hospital, Inje University, Keimyung University Dongsan Medical Center, Kokura Memorial Hospital, Nagoya Daini Nesseki Hospital, National Taiwan University Hospital, National University Heart Centre, Singapore, Queen Mary Hospital, Hong Kong, Samsung Medical Center, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital with Nanjing Medical University, Tokyo medical college hospital, Japan, Ulsan University Hospital, United Christian Hospital, Wakayama Medical University

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR 2 years after FFR measurement
See also
  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
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
Completed NCT01947439 - Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI N/A
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