NCT02208388

Brief Summary

The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Aug 2014Mar 2028

First Submitted

Initial submission to the registry

July 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

August 12, 2014

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2028

Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

13.6 years

First QC Date

July 31, 2014

Last Update Submit

April 4, 2023

Conditions

Coronary Disease

Keywords

Computed tomography perfusionFractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • Composite Events

    All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke

    1 year

Secondary Outcomes (7)

  • All cause death

    5 year

  • Myocardial infarction

    5 year

  • Target vessel revascularization

    5 year

  • Stent thrombosis

    5 year

  • Seattle Angina Questionnaire,EQ5D questionnaire

    5 year

  • +2 more secondary outcomes

Study Arms (2)

Computed tomography perfusion

EXPERIMENTAL

Patients with Computed tomography perfusion

Device: computed tomography perfusion guided treatment

Fractional flow reserve

ACTIVE COMPARATOR

Patients with Fractional flow reserve

Device: Fractional flow reserve guided treatment

Interventions

computed tomography perfusion guided treatmentDEVICE
Computed tomography perfusion
Fractional flow reserve guided treatmentDEVICE
Fractional flow reserve

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 and more
  • Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
  • Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
  • % stenosis or more in coronary CTA
  • Willing to provide informed, written consent

You may not qualify if:

  • Requirement for surgical procedure
  • Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
  • Recent STEMI (\<5 days)
  • Non STEMI, if the cardiac troponin is not stable or starting to decline
  • Left ventricular ejection fraction \<30%
  • Life expectancy \<2 years
  • Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
  • Undergoing evaluation for organ transplantation
  • Participation or planned participation in another cardiovascular clinical trial
  • Pregnancy
  • Inability to take dual antiplatelet therapy for six months
  • Previous CABG
  • Left main disease requiring revascularization
  • Any target lesion with in-stent restenosis
  • NYHA class 3 or 4a
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Asan Medical Center

Seoul, Songpa-Gu, South Korea

RECRUITING

Hallym University Sacred Heart Hospital

Anyang, South Korea

COMPLETED

Gangwon National Univ. Hospital

Chuncheon, South Korea

COMPLETED

Keimyung University Dongsan Medical Center

Daegu, South Korea

COMPLETED

Pusan National University Hospital

Pusan, South Korea

ENROLLING BY INVITATION

Pusan National University Yangsan Hospital

Pusan, South Korea

COMPLETED

Severance Hospital

Seoul, South Korea

WITHDRAWN

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Byoung-Wook Choi, MD

    Severance Hospital, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

  • Young-Hak Kim, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Hak Kim, MD

CONTACT

mdyhkim@amc.seoul.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 5, 2014

Study Start

August 12, 2014

Primary Completion (Estimated)

March 5, 2028

Study Completion (Estimated)

March 5, 2028

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

KR(7)