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

NCT07463664 | Recruiting DMC

• 2 other identifiers: 2024-KY-1551-002LHGJ20230176
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Chronic Total Occlusions of Coronary Arteries; Chronic Total Occlusion (CTO); Coronary Artery Disease (CAD)

Keywords

drug-coated balloon; Coronary artery disease; chronic total occlusion; drug-eluting stent; clinical outcome

Outcome Measures

Primary Outcomes (1)

• In-segment Late Lumen Loss, LLL

  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 Outcomes (7)

• In-segment Binary Restenosis / Re-occlusion Rate

  9 months

• Target Lesion Failure, TLF

  12 month (primary clinical assessment), 24 months, 36 months

• Cardiac Death

  12 month, 24 months, 36 months

• Clinically Driven Target Lesion Revascularization (CD-TLR)

  12 month, 24 months, 36 months

• Target Vessel Myocardial Infarction (TV-MI)

  12 month, 24 months, 36 months

Other Outcomes (3)

• Intravascular Ultrasound (IVUS) Metrics

  Immediately post-procedure, 9 months (in a pre-specified subgroup)

• Quality of Life (QoL)

  Baseline vs. 6 months, 12 months, 24 months

• Health Economics

  12 months, 24 months, 36 months

Study Arms (2)

DCB Group

EXPERIMENTAL

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

Procedure: DCB Angioplasty

DES-only Group

ACTIVE COMPARATOR

underwent Implantation with Drug-Eluting Stent-only

Procedure: DES Implantation

Interventions

DES Implantation PROCEDURE

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.

DES-only Group

DCB Angioplasty PROCEDURE

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.

DCB Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (18)

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Beijing, Beijing Municipality, 100037, China

NOT YET RECRUITING

Anyang District Hospital

Anyang, Henan, 455000, China

RECRUITING

The People's Hospital of Jiaozuo

Jiaozuo, Henan, 454002, China

NOT YET RECRUITING

The second people's Hospital of Jiyuan

Jiyuan, Henan, 454000, China

RECRUITING

Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

RECRUITING

Kaifeng Central Hospital

Kaifeng, Henan, 475000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Nanyang City Center Hospital

Nanyang, Henan, 473000, China

NOT YET RECRUITING

The Second People's Hospital of Pingdingshan

Pingdingshan, Henan, 467000, China

RECRUITING

Puyang People's Hospital

Puyang, Henan, 457099, China

RECRUITING

Yellow River Sanmenxia hospital

Sanmenxia, Henan, 472000, China

NOT YET RECRUITING

Xinyang Central Hospital

Xinyang, Henan, 464000, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of CM

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450053, China

NOT YET RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, 466000, China

RECRUITING

Jincheng People's Hospital

Jincheng, Shanxi, 048026, China

RECRUITING

Tianjin Fourth Central Hospital

Tianjin, Tianjin Municipality, 300074, China

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Chunguang Qiu, Doctor

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Central Study Contacts

Liang Pan, Doctor

CONTACT

+86-15003851743; huzhoupanliang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 11, 2026
• Study Start: April 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months to 5 years post-study completion
• 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.

Locations

CN (18)