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

NCT06164977 | Completed

• 1 other identifier: CTO_BVS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris; Coronary Artery Disease; Occlusion, Coronary

Keywords

Atherosclerosis; Chronic total coronary occlusion; Intravascular ultrasound; Optic coherence tomography

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure

  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

Study Arms (1)

Chronic total coronary occlusion

OTHER

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

Procedure: Percutaneous coronary intervention.

Interventions

Percutaneous coronary intervention. PROCEDURE

Revascularization of chronic total coronary occlusion.

Chronic total coronary occlusion

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Participant withdrawal from study.

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead

Study Sites (1)

Pauls Stradins Clinical University Hospital

Riga, Rīga, LV-1002, Latvia

Location

MeSH Terms

Conditions

Angina Pectoris; Coronary Artery Disease; Coronary Occlusion; Atherosclerosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group consists of study participants who where treated for chronic total coronary occlusion with bioresorbable scaffolds

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 11, 2023
• Study Start: February 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

LA (1)