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

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.

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Key information

Conditions

Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Coronary Occlusion Heart Diseases Myocardial Ischemia Neurologic Manifestations Occlusion, Coronary Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous coronary intervention.

Procedure

Revascularization of chronic total coronary occlusion.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Pauls Stradins Clinical University Hospital

Other

Registry information

Acronym: CTO_BVS

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Dec 11, 2023
Registry last updated: Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed