Chronic Total Coronary Occlusion Treatment Results 6 Years After Bioresorbable Scaffold Implantation (CTO_BVS)

June 6, 2025 updated by: Pauls Stradins Clinical University Hospital
Aim of the study is to evaluate chronic total coronary occlusion treatment results 6 years after bioresorbable scaffold implantation by quantitative coronary analysis, intravascular ultrasound and optical coherence tomography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to assess the outcomes of treating chronic total coronary occlusion (CTO) using bioresorbable scaffolds six years after implantation. The evaluation employs quantitative coronary analysis (QCA), intravascular ultrasound (IVUS), and optical coherence tomography (OCT) as invasive imaging tools. Clinical follow-ups were conducted at one and six years post-implantation to ensure a comprehensive understanding of the long-term safety and feasibility of bioresorbable scaffold implantation for CTO.

The primary outcome measure is defined as the target lesion failure of the treated chronic total coronary occlusion segment. Target lesion failure typically encompasses a composite endpoint that includes clinical events such as cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization.

The use of QCA allows for the quantitative assessment of the coronary arteries, providing measurements of vessel diameter and lesion length. IVUS is employed to obtain detailed images of the vessel wall, helping to visualize the morphology of the treated segment and assess the presence of any complications such as stent malapposition or edge dissections. OCT, with its high resolution, allows for detailed imaging of the coronary artery, providing information on plaque composition and stent apposition.

By combining these invasive imaging tools with clinical follow-ups at specified intervals, the study aims to provide a comprehensive evaluation of the long-term efficacy and safety of bioresorbable scaffold implantation in the treatment of chronic total coronary occlusion. The focus on target lesion failure as the primary outcome measure ensures a clinically relevant assessment of the success of the intervention.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 100% occlusion of a coronary artery for a duration of greater than or equal to 3 months based on angiographic evidence.

Exclusion Criteria:

  • Participant withdrawal from study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Chronic total coronary occlusion
Participants who underwent percutaneous coronary intervention for chronic total coronary occlusion revascularization with bioresorbable scaffold.
Procedure: Percutaneous coronary intervention.
Revascularization of chronic total coronary occlusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure
Time Frame: 6 years
Target Lesion Failure (TLF) will be assessed as the number of participants experiencing at least one of the following events during the follow-up period: cardiovascular death, clinically driven target lesion revascularization, target vessel myocardial infarction and stent thrombosis according to the Academic Research Consortium.
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pauls Stradins Clinical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO_BVS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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