Recruiting

DCB-CTODCB-Based Treatment Strategy vs DES-Only Strategy for De Novo CTO Lesions

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Study Aim

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.

What is being tested

DES Implantation

+ DCB Angioplasty

Procedure
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 80 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Zhengzhou University
Study ContactLiang Pan, Doctor
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleClinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions: A Multicenter, Randomized Controlled Trial
NCT07463664
Principal SponsorThe First Affiliated Hospital of Zhengzhou University
Study ContactLiang Pan, Doctor
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

10 inclusion criteria required to participate
Patient voluntarily participates in the study and has provided written informed consent

Presence of clinical indication for Percutaneous Coronary Intervention (PCI) of the Chronic Total Occlusion (CTO) (e.g., symptoms of angina pectoris or evidence of myocardial ischemia)

Target lesion is located in a de novo coronary artery

Angiographically confirmed CTO (TIMI grade 0 flow), with evidence supporting an occlusion duration of >= 3 months

Show More Criteria

15 exclusion criteria prevent from participating
Target CTO lesion is the culprit vessel responsible for the presenting Acute Myocardial Infarction (AMI)

Patient is in cardiogenic shock

Presence of severe heart failure (New York Heart Association [NYHA] Class IV) or Left Ventricular Ejection Fraction (LVEF) < 30%

History of stroke or Transient Ischemic Attack (TIA) within the previous 3 months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
underwent Implantation with Drug-Eluting Stent-only

Group II

Experimental
DCB-only angioplasty or hybrid strategy combining DCB and DES (DCB+DES hybrid approach)

Study 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

Recruiting

Anyang District Hospital

Anyang, ChinaOpen Anyang District Hospital in Google Maps
Recruiting

The second people's Hospital of Jiyuan

Jiyuan, China
Recruiting

Huaihe Hospital of Henan University

Kaifeng, China
Recruiting

Kaifeng Central Hospital

Kaifeng, China
Recruiting
18 Study Centers
DCB-CTO | DCB-Based Treatment Strategy vs DES-Only Strategy for De Novo CTO Lesions | PatLynk