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Coronary DiseaseASSISTNCT05529459

Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD

A study testing Percutaneous Coronary Intervention in people with Coronary Disease, run by Seung-Whan Lee, M.D., Ph.D. at 17 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is to compare clinical outcomes between quantitative coronary angiography-guided anatomic complete revascularization and fractional flow reserve-guided physiologic complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug eluting… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Percutaneous Coronary Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
17 sitesSouth Korea
Study dates
13 Mar 2023to 31 Jul 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women between the ages of 19and older
  • Typical chest pain or objective evidence of myocardial ischemia suitable for PCI Significant lesions with a diameter stenosis of 50-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Who cannot join

  • Coronary lesions resulting in the expected inability to perform FFR (ex, severe tortuosity or extreme angulation of the vessels)
  • Chronic total occlusion
  • Failed PCI of severe stenotic (diameter stenosis > 90%) or ACS culprit lesions
  • Previous PCI within 6 months before the index procedure
  • Previous coronary artery bypass graft surgery
  • Cardiogenic shock or hemodynamic instability
Show all 15Show fewer
  • Left ventricular dysfunction (ejection fraction < 35%)
  • Life expectancy < 1 years for any non-cardiac or cardiac causes
  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure
  • A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
  • Patient's pregnant or breast-feeding or child-bearing potential.
  • A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
  • Hypersensitivity or contraindication to DES material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
  • Unwillingness or inability to comply with the procedures described in this protocol

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiwon Baek, RN contact

82230107267

cvcrc22@amc.seoul.kr

Seung-Whan Lee, Investigator contact

82230103170

seungwlee@amc.seoul.kr

17 sites in 1 country

South Korea17 sites, 17 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang

    Kyoung-Ha Park, MD

    Yoon Seok Koh, MD

    Not yet recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Ha-Wook Park, MD

    Ha-Wook Park, MD

    Not yet recruiting

  • Inje University Busan Paik Hospital

    Busan

    Tae-Hyun Yang, MD

    Min Ku Chon, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Jae Seok Bae, MD, baefach@naver.com

    Jae Seok Bae, MD

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Sang Min Kim, MD

    Sang Min Kim, MD

    Recruiting

  • Daegu Veterans Hospital

    Daegu

    Jeong Hwan Cho, MD

    Jeong Hwan Cho, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Hyuck Jun Yoon, MD

    Hyuck Jun Yoon, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Hanbit Park, MD

    Hanbit Park, MD

    Recruiting

  • Wonkwang University Hospital

    Iksan

    Jae Young Cho, MD

    Jae Young Cho, MD

    Recruiting

  • Kwangju Christian Hospital

    Kwangju

    Seung Uk Lee, MD

    Seung Uk Lee, MD

    Recruiting

  • Inje University Pusan Paik Hospital

    Pusan

    Tae Hyun Yang, MD, yangthmd@naver.com

    Tae Hyun Yang, MD

    Recruiting

  • Bundang CHA Hospital

    Seongnam

    Se Hun Kang, MD

    Se Hun Kang, MD

    Not yet recruiting

  • Asan Medical Center

    Seoul

    Seung-Whan Lee, MD, seungwlee@amc.seoul.kr

    Seung-Whan Lee, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Hyungjun Joo, MD

    Hyungjun Joo, MD

    Recruiting

  • Veterans Hospital Service Medical Center

    Seoul

    Chang-Hoon Lee, MD, changhoon.lee121@gmail.com

    Chang-Hoon Lee, MD

    Recruiting

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon

    Sung-Ho Her, MD

    Sung-Ho Her, MD

    Not yet recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    mingu chon, MD

    mingu chon, MD

    Not yet recruiting

Other trials in South Korea

About this study

Official title: ASSIST Trial Anatomic Versus Physiologic Guidance for Complete Revascularization With Drug Eluting Stent Implantation in Patients With Coronary Artery Disease

This study is to compare clinical outcomes between quantitative coronary angiography-guided anatomic complete revascularization and fractional flow reserve-guided physiologic complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug eluting stent

Read the detailed description

This is a prospective, multicenter center, open-label, randomized trial to compare QCA-guided versus FFR-guided CR strategies in patients with significant CAD who are undergoing PCI with DES. Patients with symptoms or evidence of myocardial ischemia are eligible for enrollment if there have stenotic lesions with a diameter stenosis of 50%-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation, and CR is expected to be achievable by PCI. The detailed information for inclusion and exclusion criteria is described below in the session 4. Patients meeting inclusion criteria without any exclusion criteria will be randomized to either QCA-guided CR or FFR-guided CR group. In the QCA-guided CR group, PCI will be performed if there are lesions with diameter stenosis ≥ 50% by QCA during the index procedure (and, if necessary, planned staged procedure). In the FFR-guided CR group, FFR is measured for the target coronary lesions, and then PCI will be performed for the lesions with FFR ≤0.80. Post-PCI FFR measurement is strongly recommended. However, additional procedures are not recommended based on post-PCI FFR value because there is no consensus of the optimal cut-off value to define physiologic CR. In both QCA-guided and FFR-guided PCI groups, imaging guidance during PCI is left at the discretion of the operator. However, routine high pressure post-dilation with noncompliant balloons is recommended to achieve optimal stent expansion with minimal residual stenosis (diameter stenosis < 10% on visual estimation). Patients will be followed clinically at 1, 6, 12 months, and then upto 5 years after the index procedure

Being tested
Percutaneous Coronary Intervention
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionProcedure or surgery

    Percutaneous Coronary Intervention

Study groups in NCT05529459
Study groupRoleWhat they receive
quantitative coronary angiography-guided percutaneous coronary interventionExperimentalSuccessful revascularization of all coronary artery lesions or segments ≥2.25 mm* in diameter with ≥50% diameter stenosis by QCA regardless of their functional significance
Receives: Procedure: Percutaneous Coronary Intervention
fractional flow reserve-guided PCIActive comparatorSuccessful revascularization of all coronary artery lesions or segments ≥2.25 mm in diameter with evidence of ischemia or hemodynamic significance by FFR ≤ 0.80 regardless of their anatomic severity†
Receives: Procedure: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with death

    Major adverse cardiac events are defined as all-cause death

    Measured: 12month

  2. Number of Participants with MI

    Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.

    Measured: 12month

  3. Number of Participants with unplanned repeat revascularization

    Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.

    Measured: 12month

Secondary outcomes (7)

  1. Number of Participants with death

    Major adverse cardiac events are defined as all-cause death

    Measured: 5years

  2. Number of Participants with MI

    Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.

    Measured: 5years

  3. Number of Participants with unplanned repeat revascularization

    Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.

    Measured: 5years

  4. Number of Participants with bleeding

    Major or minor bleeding according to definitions from TIMI

    Measured: 5years

  5. Number of Participants with rehospitalization

    Rehospitalization for an acute coronary syndrome or repeat PCI

    Measured: 5years

  6. Self-rated health on a vertical visual analogue scale by EQ5D

    EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group and provides a simple and general questionnaire for use in clinical assessments

    Measured: 5years

  7. cost-effectiveness

    Procedure-related cost during index procedure

    Measured: 5years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start13 Mar 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05529459
Sponsor's protocol ID
2022-1298
Acronym
ASSIST
Status last verified
Jan 2025
First submitted
2 Sep 2022
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention in people with Coronary Disease, run by Seung-Whan Lee, M.D., Ph.D. at 17 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiwon Baek, RN (82230107267, cvcrc22@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with death (time frame: 12month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05529459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.

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