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

NCT ID: NCT06164977

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2023-12-01

Brief Summary

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.

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.

Conditions

Angina Pectoris; Coronary Artery Disease; Occlusion, Coronary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic total coronary occlusion

Participants who underwent percutaneous coronary intervention for chronic total coronary occlusion revascularization with bioresorbable scaffold.

Group Type: OTHER

Percutaneous coronary intervention.

Intervention Type: PROCEDURE

Revascularization of chronic total coronary occlusion.

Interventions

Percutaneous coronary intervention.

Revascularization of chronic total coronary occlusion.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pauls Stradins Clinical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pauls Stradins Clinical University Hospital

Riga, Rīga, Latvia

Countries

Latvia

Other Identifiers

CTO_BVS

Identifier Type: -

Identifier Source: org_study_id