Drug-coated balloons versus drug-eluting stents for chronic total occlusion of coronary arteries

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

This will test whether using drug-coated balloons (alone or with a stent when needed) works as well as drug-eluting stents alone for people whose chronically blocked coronary artery has been successfully opened.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Locations: 18 sites (Beijing, Beijing Municipality and 17 other locations)
• Trial ID: NCT07463664 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter randomized trial in China comparing a DCB-based strategy (DCB alone or DCB with provisional DES) to standard DES-only treatment after successful recanalization of de novo CTO lesions. The primary imaging endpoint is in-segment late lumen loss at 9 months, with secondary endpoints including target lesion failure, cardiac death, myocardial infarction, and repeat revascularization. Eligible patients must have angiographically confirmed CTO with successful guidewire crossing, adequate vessel preparation, no flow-limiting dissection, and a reference vessel diameter of 2.25–4.0 mm. Patients will be enrolled at several tertiary hospitals and followed long-term to compare safety and clinical outcomes between the two strategies.

Who should consider this trial

Good fit: Ideal candidates are adults with de novo coronary CTO who have had successful guidewire crossing and vessel preparation with restored flow, no flow-limiting dissection, and a vessel diameter between 2.25 and 4.0 mm.

Not a fit: Patients who have failed recanalization, require immediate stenting due to complications, have vessel sizes outside the 2.25–4.0 mm range, or cannot complete follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the DCB approach could reduce the need for long stents, lower risks of restenosis and stent thrombosis, shorten duration of dual antiplatelet therapy, and improve long-term outcomes.

How similar studies have performed: Drug-coated balloons have shown success in treating in-stent restenosis and small-vessel disease, but high-quality randomized data comparing DCB versus DES for de novo CTO lesions are limited, so this head-to-head comparison is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 17 other locations

• Fuwai Hospital Chinese Academy of Medical Sciences (CAMS) — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Anyang District Hospital — Anyang, Henan, China (Recruiting)
• The People's Hospital of Jiaozuo — Jiaozuo, Henan, China (Not_yet_recruiting)
• The second people's Hospital of Jiyuan — Jiyuan, Henan, China (Recruiting)
• Huaihe Hospital of Henan University — Kaifeng, Henan, China (Recruiting)
• Kaifeng Central Hospital — Kaifeng, Henan, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
• Nanyang City Center Hospital — Nanyang, Henan, China (Not_yet_recruiting)
• The Second People's Hospital of Pingdingshan — Pingdingshan, Henan, China (Recruiting)
• Puyang People's Hospital — Puyang, Henan, China (Recruiting)
• Yellow River Sanmenxia hospital — Sanmenxia, Henan, China (Not_yet_recruiting)
• Xinyang Central Hospital — Xinyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of CM — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhengzhou Central Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• People's Hospital of Zhengzhou — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhoukou Central Hospital — Zhoukou, Henan, China (Recruiting)
• Jincheng People's Hospital — Jincheng, Shanxi, China (Recruiting)
• Tianjin Fourth Central Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Liang Pan, Doctor

Conditions Chronic Total Occlusions of Coronary Arteries; Chronic Total Occlusion; Coronary Artery Disease; drug-coated balloon; Coronary artery disease; chronic total occlusion; drug-eluting stent; clinical outcome