Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions (DCB-CTO)

March 5, 2026 updated by: Chunguang Qiu, The First Affiliated Hospital of Zhengzhou University

Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions: A Multicenter, Randomized Controlled Trial

The aim of this study is to evaluate the long-term efficacy and safety of drug-coated balloon (DCB) strategies, including DCB alone or hybrid strategies of DCB and drug-eluting stent (DES), compared to DES-only in patients with chronic total occlusion (CTO) after successful recanalization. Through a prospective, multicenter randomized controlled trial, we will directly compare the long-term outcomes of these two treatment strategies in CTO patients to fill the gap in existing research regarding direct comparative data between DCB and DES in CTO treatment. This study expects to provide high-quality evidence for optimizing CTO treatment, potentially improving treatment strategies in complex cases, reducing stent usage, lowering the risk of complications, and ultimately enhancing patient prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Despite significant advances in percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO), the standard drug-eluting stent (DES) implantation strategy following successful recanalization-particularly for long-segment lesions-faces challenges associated with the "full metal jacket" phenomenon. These include increased risks of in-stent restenosis (ISR) and stent thrombosis (ST), impairment of vascular physiological function, and prolonged requirements for dual antiplatelet therapy (DAPT). Drug-coated balloon (DCB), as a "leave nothing behind" interventional technique, has demonstrated efficacy in treating DES-ISR and small vessel disease, offering a potential alternative for CTO treatment. However, its application in de novo CTO lesions remains supported by limited high-level evidence from large-scale randomized controlled trials (RCTs).

Objective This study aims to compare the long-term efficacy and safety of a DCB-based treatment strategy (including DCB alone or DCB combined with provisional DES hybrid strategy when necessary) versus standard DES-only strategy in patients with successfully recanalized native CTO lesions. The primary objective is to evaluate whether the DCB strategy is non-inferior to the DES-only strategy regarding in-segment late lumen loss (LLL) at 9 months post-procedure. Secondary objectives include comparisons of clinical endpoints (such as target lesion failure [TLF], cardiac death, myocardial infarction, and repeat revascularization), angiographic restenosis rates, patient-reported outcomes (angina, quality of life), intravascular imaging parameters, safety profiles, and cost-effectiveness between the two groups.

Methods This is a prospective, multicenter, randomized, open-label, active-controlled non-inferiority clinical trial. We plan to enroll 200 patients with successfully recanalized native CTO (reference vessel diameter 2.25-4.0 mm), who will be randomly assigned in a 1:1 ratio to either the DCB strategy group or the DES-only strategy group. The DCB group will undergo DCB angioplasty, with provisional DES implantation (hybrid strategy) permitted in cases of flow-limiting dissection or suboptimal results. The DES group will receive standard DES implantation. All patients will receive standard post-procedural medical therapy (including at least 12 months of DAPT) and will be followed up for 36 months post-procedure. The primary endpoint of in-segment LLL at 9 months will be assessed by an independent core laboratory, blinded to group allocation, using quantitative coronary angiography (QCA). Clinical endpoint events will be adjudicated by an independent Clinical Events Committee (CEC). Statistical analysis will be primarily based on the intention-to-treat (ITT) principle.

Expected Significance This study (the DCB-CTO Study) is expected to provide the first large-scale RCT evidence directly comparing DCB strategy versus DES-only strategy for de novo CTO. The findings will furnish clinicians with important evidence-based guidance for managing this complex lesion subset, potentially optimizing interventional treatment strategies for CTO, reducing metallic implant burden, and possibly improving long-term clinical outcomes for patients.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Not yet recruiting
        • Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
        • Contact:
        • Principal Investigator:
          • Ru Liu
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang District Hospital
        • Contact:
        • Principal Investigator:
          • Yongcun Hu
      • Jiaozuo, Henan, China, 454002
        • Not yet recruiting
        • The People's Hospital of Jiaozuo
        • Contact:
        • Principal Investigator:
          • Haijun Zheng
      • Jiyuan, Henan, China, 454000
        • Recruiting
        • The second people's Hospital of Jiyuan
        • Contact:
        • Principal Investigator:
          • Runlu Xue
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Huaihe Hospital of Henan University
        • Contact:
        • Principal Investigator:
          • Xiaoming Zhong
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Kaifeng Central Hospital
        • Contact:
        • Principal Investigator:
          • Jieyun Liu
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Principal Investigator:
          • Zhijuan Li
        • Contact:
      • Nanyang, Henan, China, 473000
        • Not yet recruiting
        • Nanyang City Center Hospital
        • Contact:
        • Principal Investigator:
          • Zhiliang Zhang
      • Pingdingshan, Henan, China, 467000
        • Recruiting
        • The Second People's Hospital of Pingdingshan
        • Principal Investigator:
          • Ling Zhang
        • Contact:
      • Puyang, Henan, China, 457099
        • Recruiting
        • Puyang People's Hospital
        • Contact:
        • Principal Investigator:
          • Wenyuan Wang
      • Sanmenxia, Henan, China, 472000
        • Not yet recruiting
        • Yellow River Sanmenxia Hospital
        • Contact:
        • Principal Investigator:
          • Chaohong Zhang
      • Xinyang, Henan, China, 464000
        • Not yet recruiting
        • Xinyang Central Hospital
        • Contact:
        • Principal Investigator:
          • Tan Xu
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Zhengzhou Central Hospital
        • Principal Investigator:
          • Dan Wang
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of CM
        • Contact:
        • Principal Investigator:
          • Minghua Luo
      • Zhengzhou, Henan, China, 450053
        • Not yet recruiting
        • People's Hospital of Zhengzhou
        • Contact:
        • Principal Investigator:
          • Dongyu Wan
      • Zhoukou, Henan, China, 466000
        • Recruiting
        • Zhoukou Central Hospital
        • Contact:
        • Principal Investigator:
          • Guoli Jia
    • Shanxi
      • Jincheng, Shanxi, China, 048026
        • Recruiting
        • Jincheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Sancong Pan, Doctor
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300074
        • Not yet recruiting
        • Tianjin Fourth Central Hospital
        • Contact:
        • Principal Investigator:
          • Shangyu Wen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Successful guidewire crossing of the target CTO lesion has been achieved during the index procedure.
  • After adequate vessel preparation: Distal TIMI grade 3 flow has been restored; Target lesion residual diameter stenosis is < 50% (e.g., by visual estimate or QCA as per protocol); Absence of flow-limiting dissection or other complications requiring immediate stent implantation.
  • Target vessel Reference Vessel Diameter (RVD) is between 2.25 mm and 4.0 mm (inclusive, assessed by visual estimate or QCA/IVUS as per protocol).
  • In the judgment of the interventional operator, the lesion is deemed suitable for treatment with both a Drug-Coated Balloon (DCB)-based strategy and a Drug-Eluting Stent (DES)-only strategy.
  • Patient is able and willing to comply with the study protocol requirements, including the specified follow-up schedule.
  • Female patients of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use an effective method of contraception throughout the study period.

Exclusion Criteria:

  • 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.
  • Known high risk of bleeding or contraindication to Dual Antiplatelet Therapy (DAPT).
  • Presence of severe hepatic impairment and/or severe renal impairment (e.g., estimated Glomerular Filtration Rate [eGFR] < 30 ml/min/1.73m² or requirement for chronic dialysis).
  • Known hypersensitivity or contraindication to required study medications (e.g., antiplatelet agents, contrast media), DCB/DES drug coatings, or device materials (e.g., stent alloys, polymers).
  • Target lesion located in an unprotected left main coronary artery, a saphenous vein graft, or an arterial graft.
  • Presence of severe lesion calcification that prevents adequate vessel expansion despite attempted lesion preparation techniques (e.g., rotational atherectomy, intravascular lithotripsy).
  • Target lesion is a CTO within a previously stented segment (In-Stent Restenosis [ISR] or In-Stent Thrombosis [IST]).
  • Failed attempt at CTO recanalization during the index procedure (i.e., failure to cross the lesion with a guidewire or failure to restore TIMI grade 3 flow).
  • Occurrence of a complication after vessel preparation that necessitates immediate stent implantation (e.g., flow-limiting dissection, perforation requiring a covered stent).
  • Concurrent enrollment in another interventional clinical trial that may interfere with the study endpoints or assessments.
  • Female patient is pregnant or breastfeeding.
  • Patient judged by the investigator to be unsuitable for the study for any reason, including anticipated poor compliance with the protocol.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCB Group
DCB-only angioplasty or hybrid strategy combining DCB and DES (DCB+DES hybrid approach)
Procedure: DCB Angioplasty
Drug-coated balloons meeting study criteria (e.g., paclitaxel- or sirolimus-coated DCB; specific models selected by operators according to clinical practice) were chosen. DCB diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm proximal and distal to the lesion. DCB inflation was maintained for ≥60 seconds at 8-12 atm to ensure adequate drug delivery to the vessel wall. Intraoperative angiography confirmed <50% residual stenosis, TIMI grade 3 flow, and absence of serious complications. DES implantation was permitted (recorded as hybrid strategy) if any of the following conditions occurred after DCB application: Residual stenosis ≥50% with hemodynamic significance; Non-flow-limiting dissection requiring stent support based on operator judgment; Other technical difficulties resulting in DCB-alone treatment failure. DES selection was consistent with the DES-only group.
Active Comparator: DES-only Group
underwent Implantation with Drug-Eluting Stent-only
Procedure: DES Implantation
Drug-eluting stents meeting study criteria (e.g., sirolimus-, paclitaxel-, or everolimus-eluting stents; specific models selected by operators according to clinical practice) were chosen. Stent diameter was determined by the target vessel reference diameter (2.25-4.0 mm), with length covering the occluded segment plus 5 mm of healthy vessel proximal and distal to the lesion. Stents were deployed at 8-16 atm to ensure optimal apposition. Intraoperative angiography confirmed no residual stenosis (<10%) and TIMI grade 3 flow. When multiple stents were required, an overlapping technique was utilized to ensure complete lesion coverage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-segment Late Lumen Loss, LLL
Time Frame: 9 months
Measured via planned, mandatory follow-up coronary angiography. Standardized, blinded analysis performed by an independent core laboratory using Quantitative Coronary Angiography (QCA). The "segment" is defined as the target lesion plus 5 mm proximal and distal margins. LLL = Post-procedure Minimum Lumen Diameter (MLD_post-procedure) - Follow-up Minimum Lumen Diameter (MLD_follow-up).
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-segment Binary Restenosis / Re-occlusion Rate
Time Frame: 9 months
Determined by core laboratory QCA analysis. Defined as diameter stenosis ≥50% or TIMI 0 flow in the target lesion segment (consistent with LLL segment definition) on follow-up angiography.
9 months
Target Lesion Failure, TLF
Time Frame: 12 month (primary clinical assessment), 24 months, 36 months
Assessed through clinical follow-up, adjudicated by an independent Clinical Events Committee (CEC). Composite endpoint includes the first occurrence of cardiac death, target vessel myocardial infarction (TV-MI, per SCAI definition), or clinically driven target lesion revascularization (CD-TLR).
12 month (primary clinical assessment), 24 months, 36 months
Cardiac Death
Time Frame: 12 month, 24 months, 36 months
Determined through clinical follow-up, adjudicated by CEC. Defined as any death due to a confirmed cardiovascular cause or sudden death where a cardiovascular cause cannot be excluded.
12 month, 24 months, 36 months
Clinically Driven Target Lesion Revascularization (CD-TLR)
Time Frame: 12 month, 24 months, 36 months
Evaluated via clinical follow-up and angiography, adjudicated by CEC. Defined as revascularization driven by symptoms (e.g., angina) or ischemic evidence, with angiographic confirmation of target lesion diameter stenosis ≥50% or occlusion requiring intervention.
12 month, 24 months, 36 months
Target Vessel Myocardial Infarction (TV-MI)
Time Frame: 12 month, 24 months, 36 months
Assessed through clinical follow-up, adjudicated by CEC per SCAI definition. Requires target vessel-related electrocardiographic changes (new Q-wave or ST-segment elevation) and biomarker elevation (troponin >5 times upper limit of normal).
12 month, 24 months, 36 months
Very Late Clinical Events
Time Frame: 24个月、36个月
Assessed through clinical follow-up, adjudicated by CEC. Includes TLF and Major Adverse Cardiovascular Events (MACE, comprising cardiac death, MI, target vessel revascularization) occurring >1 year post-procedure.
24个月、36个月
Angina Status Change (CCS Grading or SAQ Score Change)
Time Frame: Baseline vs. 6 months, 12 months, 24 months
Evaluated using Canadian Cardiovascular Society (CCS) grading or Seattle Angina Questionnaire (SAQ) to assess angina frequency, severity, and physical limitation. Patient-reported data collected by study coordinators, aggregated in a blinded manner.
Baseline vs. 6 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravascular Ultrasound (IVUS) Metrics
Time Frame: Immediately post-procedure, 9 months (in a pre-specified subgroup)
Performed in a designated subgroup immediately post-procedure and at 9-month follow-up. IVUS measures Minimum Lumen Area (MLA), etc. Blinded analysis conducted by the core laboratory.
Immediately post-procedure, 9 months (in a pre-specified subgroup)
Quality of Life (QoL)
Time Frame: Baseline vs. 6 months, 12 months, 24 months
Assessed using the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionnaire to evaluate health-related quality of life. It assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with levels ranging from "no problems" to "extreme problems," plus a 0-100 visual analogue scale (VAS) for self-rated health. Patient-reported data collected by study coordinators, with utility scores calculated.
Baseline vs. 6 months, 12 months, 24 months
Health Economics
Time Frame: 12 months, 24 months, 36 months
Assessed through Cost-Effectiveness Analysis (CEA) and Cost-Utility Analysis (CUA). Direct medical costs and indirect costs are collected. Utility is measured in Quality-Adjusted Life Years (QALYs) derived from EQ-5D scores. Data are aggregated by the study coordinating center, calculating the Incremental Cost-Effectiveness Ratio (ICER).
12 months, 24 months, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Study Chair: Chunguang Qiu, Doctor, the First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-1551-002
  • LHGJ20230176 (Other Grant/Funding Number: Health Commission of Henan Province)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets used and/or analyzed in the current study will be uploaded to the public clinical trial management platform ResMan (http://www.medresman.org.cn).

IPD Sharing Time Frame

6 months to 5 years post-study completion

IPD Sharing Access Criteria

Qualified researchers who provide a methodologically sound proposal and have appropriate ethical approvals. Requests will be reviewed by an independent review committee.

De-identified individual participant data (IPD) underlying published results, including study protocol, statistical analysis plan, informed consent form, and analytic code.

Data will be available via a secure online platform ResMan (http://www.medresman.org.cn). upon approval of data use agreement and completion of required training.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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