DCB-CTODCB-Based Treatment Strategy vs DES-Only Strategy for De Novo CTO Lesions
This study aims to compare the effectiveness of a DCB-Based Treatment Strategy versus a DES-Only Strategy for De Novo CTO Lesions, by measuring In-segment Late Lumen Loss through a planned, mandatory follow-up coronary angiography.
DES Implantation
+ DCB Angioplasty
Arterial Occlusive Diseases+5
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: April 28, 2025
Actual date on which the first participant was enrolled.This study focuses on treating patients who have a specific type of heart disease called coronary chronic total occlusion (CTO). CTO is a condition where a coronary artery is completely blocked. The study aims to compare two treatment strategies: one using a drug-coated balloon (DCB) and the other using a standard drug-eluting stent (DES). The DCB is a 'leave nothing behind' technique that has shown promise in treating certain heart conditions, but its use in CTO is not yet fully understood. The study aims to see if the DCB treatment is as effective and safe as the standard DES treatment. This research is important as it could potentially offer a new treatment option for CTO patients, reducing the risk of complications and improving long-term outcomes. In this study, 200 patients with successfully recanalized native CTO will be randomly assigned to either the DCB group or the DES group. The DCB group will receive DCB angioplasty, with the option of DES implantation if necessary. The DES group will receive standard DES implantation. All patients will receive standard post-procedure medication and will be followed up for 36 months. The main outcome measure is the change in the narrowing of the blood vessel at 9 months, which will be assessed using a special x-ray technique. The study will also look at other outcomes such as heart-related events, quality of life, and cost-effectiveness.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
The second people's Hospital of Jiyuan
Jiyuan, ChinaHuaihe Hospital of Henan University
Kaifeng, ChinaKaifeng Central Hospital
Kaifeng, China