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Coronary Artery DiseaseRENOVATENCT03381872

Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease

A study testing Percutaneous coronary intervention for complex lesion, Drug-eluting stent and Intravascular imaging (IVUS or OCT) in people with Coronary Artery Disease and Atherosclerosis, run by Samsung Medical Center at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of the study is to compare clinical outcomes between intravascular imaging-guided versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease, Atherosclerosis
What is being tested?
Percutaneous coronary intervention for complex lesion, Drug-eluting stent and Intravascular imaging (IVUS or OCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,639 participants
Where
1 siteSouth Korea
Study dates
10 May 2018to 31 Dec 2025
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

  • Subject age ≥19 years old
  • Coronary artery disease requiring PCI
  • Patients with complex lesion
  • True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
  • Chronic total occlusion (≥3 months) as target lesion
  • Unprotected LM disease PCI (LM ostium, body, distal LM bifurcation including non-true bifurcation)
Show all 13Show fewer
  • Long coronary lesions (implanted stent ≥38 mm in length)
  • Multi-vessel PCI (≥2 vessels treated at one PCI session)
  • Multiple stents needed (≥3 more stent per patient)
  • In-stent restenosis lesion as target lesion
  • Severely calcified lesion (encircling calcium in angiography)
  • Ostial coronary lesion (LAD, LCX, RCA)
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Who cannot join

  • Target lesions not amenable for PCI by operators' decision
  • Cardiogenic shock (Killip class IV) at presentation
  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
  • Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
  • Pregnancy or breast feeding
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • Unwillingness or inability to comply with the procedures described in this protocol.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention (RENOVATE-COMPLEX-PCI)

The aim of the study is to compare clinical outcomes between intravascular imaging-guided versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions.

Read the detailed description

After introduction of the 2nd generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decreased, compared with the era of bare metal stents or 1st generation DES. Nevertheless, patients undergoing percutaneous coronary intervention (PCI) for complex lesions, for example, chronic total occlusion (CTO), left main disease, true bifurcation lesion, long lesion, multi-vessel PCI, multiple overlapping stents, or severely calcified lesions have significantly worse clinical outcomes than those with non-complex lesions.

During the PCI procedure, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are useful tools for providing information on preintervention lesion characteristics, including vulnerable plaques, lesion severity, length, and morphology; on postintervention optimal stent implantation for stent expansion, extension, and apposition; and on possible complications after stent implantation. Therefore, intravascular imaging guidance may improve clinical outcomes after complex PCI. However, although previous randomized controlled trial (RCT) and registries showed significantly lower rates of major adverse clinical events following IVUS-guided PCI compared with angiography-guided PCI, the RCTs were limited with small sample size and dealt with very selected lesion subsets such as CTO or long lesion. Moreover, it is uncertain whether OCT-guided PCI improves clinical outcomes compared with angiography-guided PCI. Meanwhile, appropriate imaging modality may differ according to patient and lesion characteristics.

One of the ways to maximize the advantage of intravascular imaging is choice of intravascular imaging devices by the operator's discretion. Therefore, the current RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) is designed to investigate whether PCI under guidance of intravascular imaging devices (IVUS or OCT) chosen by operators would improve clinical outcomes compared with angiography-guided PCI in patients with complex lesions.

Being tested
Percutaneous coronary intervention for complex lesion, Drug-eluting stent, Intravascular imaging (IVUS or OCT), Drug-coated balloon
Keywords
Intravascular Imaging, Intravascular Ultrasound, Optical Coherence Tomography, Complex Lesion, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease, Atherosclerosis

What participants receive

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

  • Percutaneous coronary intervention for complex lesionProcedure or surgery

    In patients who have complex coronary lesions, PCI will performed using intravascular imaging or angiography only according to the allocated arms

    1. Intravascular imaging arm
    2. Angiography arm
    • Definition of Complex Lesions
    1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
    2. Chronic total occlusion (≥3 months) as target lesion
    3. PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
    4. Implanted stent length ≥38mm
    5. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
    6. Multiple stent needed (≥3 more stent per patient)
    7. In-stent restenosis lesion as target lesion
    8. Severely calcified lesion (encircling calcium in angiography)
    9. Ostial coronary lesion (LAD, LCX, RCA)

  • Drug-eluting stentDevice

    All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.

  • Intravascular imaging (IVUS or OCT)Device

    IVUS Reference site: Largest lumen, Plaque burden <50% Stent sizing: By measuring vessel diameter (external elastic membrane) at proximal and distal reference sites. The averaged value of the proximal and distal reference external elastic membrane diameter will be used as stent diameter

    OCT Reference site: Most normal looking segment, No Lipidic plaque Stent sizing: [1] By measuring vessel diameter at the distal reference sites (in case of ≥180° of the external elastic membrane can be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25 mm.

    [2] By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25 mm.

  • Drug-coated balloonDevice

    All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.

Study groups in NCT03381872
Study groupRoleWhat they receive
Intravascular imaging armActive comparatorThe choice of intravascular imaging devices such as IVUS or OCT during PCI will be left to the operator's discretion. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended. Use of intravascular imaging devices will be allowed at any step of PCI (pre-PCI, during PCI and post-PCI), but intravascular imaging evaluation after stent implantation will be mandatory.
Receives: Procedure: Percutaneous coronary intervention for complex lesion; Device: Drug-eluting stent; Device: Intravascular imaging (IVUS or OCT); Device: Drug-coated balloon
Angiography armActive comparatorThe PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 10% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
Receives: Procedure: Percutaneous coronary intervention for complex lesion; Device: Drug-eluting stent; Device: Drug-coated balloon

What is being measured

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

  1. Target vessel Failure

    A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization

    Measured: 1-year after last patient enrollment

Secondary outcomes (32)

  1. Target vessel failure without procedure-related MI

    A composite of cardiac death, spontaneous target vessel MI, and clinically-driven target vessel revascularization

    Measured: 1-year after last patient enrollment

  2. Cardiac death or target-vessel related MI

    Cardiac death or target-vessel related MI

    Measured: 1-year after last patient enrollment

  3. All-cause death

    any death

    Measured: 1-year after last patient enrollment

  4. Cardiac death

    cardiac death

    Measured: 1-year after last patient enrollment

  5. Target vessel MI with procedure-related MI

    Target vessel MI with procedure-related MI

    Measured: 1-year after last patient enrollment

  6. Target vessel MI without procedure-related MI

    Target vessel MI without procedure-related MI

    Measured: 1-year after last patient enrollment

  7. Any MI with procedure-related MI

    Any MI with procedure-related MI

    Measured: 1-year after last patient enrollment

  8. Any MI without procedure-related MI

    Any MI without procedure-related MI

    Measured: 1-year after last patient enrollment

  9. Non-target vessel related MI

    Non-target vessel related MI

    Measured: 1-year after last patient enrollment

  10. Target lesion revascularization

    TLR

    Measured: 1-year after last patient enrollment

  11. Target vessel revascularization

    TVR

    Measured: 1-year after last patient enrollment

  12. Any revascularization

    clinically-driven revascularization

    Measured: 1-year after last patient enrollment

  13. Stent thrombosis

    definite stent thrombosis

    Measured: 1-year after last patient enrollment

  14. Incidence of contrast-induced nephropathy

    CIN was defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure

    Measured: 48-72 hours after index procedure

  15. Total amount of contrast use

    Total amount of contrast use during index hospitalization

    Measured: Immediate after index procedure

  16. Total procedure time

    Total procedure time during index hospitalization

    Measured: Immediate after index procedure

  17. Total medical cost

    Total medical cost

    Measured: 1-year after last patient enrollment

  18. Target vessel Failure

    A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization

    Measured: 4 years after last patient enrollment

  19. Target vessel failure without procedure-related MI

    A composite of cardiac death, spontaneous target vessel MI, and clinically-driven target vessel revascularization

    Measured: 4 years after last patient enrollment

  20. All-cause death

    any death

    Measured: 4 years after last patient enrollment

  21. Cardiac death

    cardiac death

    Measured: 4 years after last patient enrollment

  22. Target vessel MI with procedure-related MI

    Target vessel MI with procedure-related MI

    Measured: 4 years after last patient enrollment

  23. Target vessel MI without procedure-related MI

    Target vessel MI without procedure-related MI

    Measured: 4 years after last patient enrollment

  24. Any MI with procedure-related MI

    Any MI with procedure-related MI

    Measured: 4 years after last patient enrollment

  25. Any MI without procedure-related MI

    Any MI without procedure-related MI

    Measured: 4 years after last patient enrollment

  26. Non-target vessel related MI

    Non-target vessel related MI

    Measured: 4 years after last patient enrollment

  27. Target lesion revascularization

    TLR

    Measured: 4 years after last patient enrollment

  28. Target vessel revascularization

    TVR

    Measured: 4 years after last patient enrollment

  29. Any revascularization

    clinically-driven revascularization

    Measured: 4 years after last patient enrollment

  30. Stent thrombosis

    definite stent thrombosis

    Measured: 4 years after last patient enrollment

  31. Bleeding (BARC definition)

    BARC Classification (2,3, or 5)

    Measured: 4 years after last patient enrollment

  32. Bleeding (TIMI definition)

    TIMI Classification (Minimal, Minor, Major)

    Measured: 4 years after last patient enrollment

Timeline

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

  1. First posted22 Dec 2017
  2. Study start10 May 2018
  3. Primary completion10 May 2022
  4. Study completion31 Dec 2025 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, open label, two-arm, randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,639 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381872
Sponsor's protocol ID
Renovate16453143
Acronym
RENOVATE
Status last verified
Aug 2025
First submitted
16 Dec 2017
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Publications

  • Lee JM, Kim O, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE COMPLEX-PCI Investigators. Intravascular Imaging- vs Angiography-Guided Complex PCI: 5-Year Outcomes From a Randomized Trial. J Am Coll Cardiol. 2026 Apr 28;87(16):2099-2113. doi: 10.1016/j.jacc.2026.01.035. Epub 2026 Mar 4.

    PubMed 41778943

  • Jo J, Lee SY, Kwon W, Lee SJ, Lee JY, Lee SH, Shin D, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee SY, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Versus Angiography-Guided Complex PCI in Patients With High Bleeding Risk: A Secondary Analysis of the RENOVATE-COMPLEX PCI Trial. Circ Cardiovasc Interv. 2025 Mar;18(3):e014952. doi: 10.1161/CIRCINTERVENTIONS.124.014952. Epub 2025 Mar 18.

    PubMed 40100948

  • Lee JM, Lee SY, Kwon W, Lee SJ, Lee JY, Lee SH, Shin D, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging Predictors Associated With Cardiovascular Events After Complex PCIs. Circ Cardiovasc Interv. 2025 Feb;18(2):e014920. doi: 10.1161/CIRCINTERVENTIONS.124.014920. Epub 2025 Feb 18.

    PubMed 39965046

  • Lee SY, Lee SJ, Kwon W, Lee SH, Shin D, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee JY, Lee JM, Investigators TR. Outcomes of intravascular imaging-guided percutaneous coronary intervention according to lesion complexity. EuroIntervention. 2025 Feb 3;21(3):e171-e182. doi: 10.4244/EIJ-D-24-00755.

    PubMed 39901632

  • Hong D, Ha J, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Park TK, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Prognostic impact of intravascular imaging in percutaneous coronary intervention according to atherothrombotic risk: a post hoc analysis of a randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2025 Jun;78(6):542-552. doi: 10.1016/j.rec.2024.11.007. Epub 2024 Dec 4. English, Spanish.

    PubMed 39643207

  • Choi KH, Park TK, Song YB, Lee JM, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Yang JH, Choi SH, Gwon HC, Hahn JY, Nam CW; RENOVATE COMPLEX-PCI Investigators. Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417613. doi: 10.1001/jamanetworkopen.2024.17613.

    PubMed 38913377

  • Lee SY, Choi KH, Kim CJ, Lee JM, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Kim SE, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Impact of Intravascular Imaging-Guided Stent Optimization According to Clinical Presentation in Patients Undergoing Complex PCI. JACC Cardiovasc Interv. 2024 May 27;17(10):1231-1243. doi: 10.1016/j.jcin.2024.03.021.

    PubMed 38811104

  • Cha JH, Lee JM, Choi KH, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY, Lee WS, Song YB; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial. JAMA Cardiol. 2024 May 1;9(5):466-474. doi: 10.1001/jamacardio.2024.0291.

    PubMed 38568686

  • Hong D, Lee J, Lee H, Cho J, Guallar E, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Kang D, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Cost-Effectiveness of Intravascular Imaging-Guided Complex PCI: Prespecified Analysis of RENOVATE-COMPLEX-PCI Trial. Circ Cardiovasc Qual Outcomes. 2024 Mar;17(3):e010230. doi: 10.1161/CIRCOUTCOMES.123.010230. Epub 2024 Mar 13.

    PubMed 38477162

  • Kwon W, Hong D, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Percutaneous Coronary Intervention Before and After Standardized Optimization Protocols. JACC Cardiovasc Interv. 2024 Jan 22;17(2):292-303. doi: 10.1016/j.jcin.2023.10.062.

    PubMed 38267144

  • Kwon W, Choi KH, Song YB, Park YH, Lee JM, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE COMPLEX-PCI Investigators. Intravascular Imaging in Patients With Complex Coronary Lesions and Chronic Kidney Disease. JAMA Netw Open. 2023 Nov 1;6(11):e2345554. doi: 10.1001/jamanetworkopen.2023.45554.

    PubMed 38019512

  • Kwon W, Lee JM, Yun KH, Choi KH, Lee SJ, Lee JY, Lee SY, Kim SM, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY, Song YB; RENOVATE COMPLEX-PCI Investigators. Clinical Benefit of Intravascular Imaging Compared With Conventional Angiography in Left Main Coronary Artery Intervention. Circ Cardiovasc Interv. 2023 Dec;16(12):e013359. doi: 10.1161/CIRCINTERVENTIONS.123.013359. Epub 2023 Nov 29.

    PubMed 38018841

  • Lee JM, Choi KH, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided or Angiography-Guided Complex PCI. N Engl J Med. 2023 May 4;388(18):1668-1679. doi: 10.1056/NEJMoa2216607. Epub 2023 Mar 5.

    PubMed 36876735

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention for complex lesion, Drug-eluting stent and Intravascular imaging (IVUS or OCT) in people with Coronary Artery Disease and Atherosclerosis, run by Samsung Medical Center at 1 site 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 13 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target vessel Failure (time frame: 1-year after last patient enrollment). 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 NCT03381872, which also lists 13 linked publications.

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 22 Aug 2025.

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