Actively Recruiting
Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2026-03-11
200
Participants Needed
18
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily participates and has provided written informed consent
- Clinical indication for PCI of chronic total occlusion (symptoms or evidence of ischemia)
- Target lesion is a de novo coronary artery
- Angiographically confirmed CTO with TIMI grade 0 flow and occlusion duration ≥ 3 months
- Successful guidewire crossing of the target CTO lesion during the index procedure
- After vessel preparation: distal TIMI grade 3 flow restored; residual stenosis < 50%; no flow-limiting dissection or complications
- Target vessel diameter between 2.25 mm and 4.0 mm
- Lesion suitable for treatment with both DCB and DES strategies as judged by the operator
- Able and willing to comply with study protocol and follow-up schedule
- Female participants of childbearing potential have negative pregnancy test and agree to use contraception during study
You will not qualify if you...
- Target CTO lesion is culprit vessel of acute myocardial infarction
- Cardiogenic shock
- Severe heart failure (NYHA class IV) or left ventricular ejection fraction < 30%
- Stroke or transient ischemic attack within the past 3 months
- High bleeding risk or contraindication to dual antiplatelet therapy
- Severe hepatic or renal impairment (eGFR < 30 ml/min/1.73m² or dialysis requirement)
- Known hypersensitivity or contraindication to study medications, DCB/DES drug coatings, or device materials
- Target lesion in unprotected left main coronary artery, saphenous vein graft, or arterial graft
- Severe lesion calcification preventing adequate vessel expansion despite preparation
- CTO within previously stented segment (in-stent restenosis or thrombosis)
- Failed CTO recanalization during index procedure
- Complications after vessel preparation requiring immediate stenting
- Concurrent enrollment in another interventional trial interfering with study
- Pregnancy or breastfeeding
- Investigator judgment of unsuitability including anticipated poor protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, China, 100037
Not Yet Recruiting
2
Anyang District Hospital
Anyang, Henan, China, 455000
Actively Recruiting
3
The People's Hospital of Jiaozuo
Jiaozuo, Henan, China, 454002
Not Yet Recruiting
4
The second people's Hospital of Jiyuan
Jiyuan, Henan, China, 454000
Actively Recruiting
5
Huaihe Hospital of Henan University
Kaifeng, Henan, China, 475000
Actively Recruiting
6
Kaifeng Central Hospital
Kaifeng, Henan, China, 475000
Actively Recruiting
7
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
8
Nanyang City Center Hospital
Nanyang, Henan, China, 473000
Not Yet Recruiting
9
The Second People's Hospital of Pingdingshan
Pingdingshan, Henan, China, 467000
Actively Recruiting
10
Puyang People's Hospital
Puyang, Henan, China, 457099
Actively Recruiting
11
Yellow River Sanmenxia hospital
Sanmenxia, Henan, China, 472000
Not Yet Recruiting
12
Xinyang Central Hospital
Xinyang, Henan, China, 464000
Not Yet Recruiting
13
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
14
Zhengzhou Central Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
15
People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450053
Not Yet Recruiting
16
Zhoukou Central Hospital
Zhoukou, Henan, China, 466000
Actively Recruiting
17
Jincheng People's Hospital
Jincheng, Shanxi, China, 048026
Actively Recruiting
18
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, China, 300074
Not Yet Recruiting
Research Team
L
Liang Pan, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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