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NCT03381872Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 22 Aug 2025

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1639 (actual)
First submitted
16 Dec 2017
Start date
10 May 2018
Primary completion date
10 May 2022
Lead sponsor
Samsung Medical Center
NCT number
NCT03381872

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1639
  • From 10 May 2018 to the primary completion date, 10 May 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
  • 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)

Other

  • 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
  • Pregnancy or breast feeding
  • Unwillingness or inability to comply with the procedures described in this protocol.

Who the study is looking for

  • 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)
    • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.