Predictors and Long-term Incidence of In-stent Restenosis After Chronic Total Occlusion Percutaneous Coronary Intervention

NCT07473596 | Completed

• 1 other identifier: HUS/12527/2022
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to describe the long-term (≥ 3 years) patency of coronary artery stents following chronic total occlusion percutaneous coronary intervention (CTO PCI). The main questions it aims to answer are:

• What is the incidence of in-stent restenosis after CTO PCI?
• What are patient-, lesion-, and procedure-related factors associated with an increased risk of in-stent restenosis after CTO PCI?

Conditions

Chronic Total Occlusion of Coronary Artery; Coronary Artery Disease (CAD); Chronic Total Occlusion (CTO)

Keywords

coronary artery disease; drug-eluting stent; percutaneous coronary intervention; in-stent restenosis; chronic total occlusion

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of long-term ISR after CTO PCI

  ISR was defined as a ≥ 50 % luminal diameter narrowing within the coronary artery stent.

  Through study completion, up to 10.9 years, with an average follow-up of 7.1 years.

Other Outcomes (2)

• Incidence of procedural complications

  Perioperative/Periprocedural

• Incidence of clinical endpoints

  Through study completion, up to 10.9 years, with an average follow-up of 7.1 years.

Study Arms (1)

Study population

OTHER

All patients included in the study

Procedure: chronic total occlusion percutaneous coronary intervention (CTO PCI); Diagnostic Test: coronary computed tomography angiography; Diagnostic Test: invasive coronary angiography

Interventions

chronic total occlusion percutaneous coronary intervention (CTO PCI) PROCEDURE

All patients in the study have received CTO PCI with a drug-eluting stent.

Study population

coronary computed tomography angiography DIAGNOSTIC_TEST

Patients meeting the surveillance imaging criteria received computed tomography angiography.

Study population

invasive coronary angiography DIAGNOSTIC_TEST

According to the study criteria, some of the patients received confirmation imaging with invasive coronary angiography after coronary computed tomography angiography.

Study population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful CTO PCI with a drug-eluting stent
• Primary procedure minimum of 3 years prior to study date
• Of the included patients, CTO stent patency surveillance imaging with CCTA was conducted according to the following criteria. Patients were consecutive and prospectively recruited.
• Surviving patients ≤ 80 years old at the time of surveillance imaging
• Communication in Finnish, Swedish or English

You may not qualify if:

• Target lesion revascularisation or angiographically verified ISR after CTO PCI
• Malignancy with ongoing diagnostics or poor prognosis
• Considerable functional impairment in activities of daily living
• Presence of a clinically significant psychiatric disorder
• Ongoing alcohol or drug abuse
• Presence of a memory disorder or other clinically significant cognitive impairment
• Coronary artery bypass surgery (CABG) after CTO PCI
• Estimated glomerular filtration rate ≤40 ml/min
• invasive coronary angiography performed less than 6 months prior to the surveillance imaging date
• CCTA results were reviewed by the interventional cardiologists of the study and ICA was offered to patients with:
• ISR or an inconclusive finding within the CTO stent.
• Anginal symptoms with either ≥ 50 % stenosis or an inconclusive finding in any native coronary artery or within a non-CTO stent.

Sponsors & Collaborators

• Lauri Mansikkaniemi: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00290, Finland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Petri Laine, Ph.D.

  Department of Cardiology, Heart and Lung Center, Helsinki University Central Hospital and University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study's cardiac radiologist was blinded for symptomatic data, stent type and stent quantity. The target vessel of implanted coronary artery stents was provided.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: March 16, 2026
• Study Start: January 16, 2023
• Primary Completion: February 6, 2025
• Study Completion: February 24, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)