Actively Recruiting
Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions: A Multicenter, Randomized Controlled Trial
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2026-03-11
200
Participants Needed
18
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term effectiveness and safety of drug-coated balloon (DCB) strategies, including DCB alone or combined with drug-eluting stents (DES), compared to DES-only treatment in patients with chronic total occlusion (CTO) of coronary arteries after successful reopening. This multicenter randomized controlled trial aims to fill the gap in direct comparative data between DCB and DES treatments for CTO, with the goal of optimizing treatment strategies, reducing stent use, lowering complication risks, and improving patient outcomes. Participants will be randomly assigned to either the DCB group, which involves balloon angioplasty with drug coating and possible provisional DES implantation if needed (hybrid strategy), or the DES-only group receiving standard drug-eluting stent placement. Both groups receive standard medical therapy including at least 12 months of dual antiplatelet therapy (DAPT). The study includes a 9-month primary endpoint assessment and a 36-month follow-up period to monitor long-term outcomes. During the study, patients will undergo angiographic evaluation for late lumen loss at 9 months, assessed by an independent laboratory using quantitative coronary angiography. Clinical events such as target lesion failure, cardiac death, myocardial infarction, and repeat revascularization will be monitored up to 36 months. Patient-reported outcomes like angina status and quality of life, as well as intravascular imaging and safety parameters, will also be collected. Overall participation spans over three years with regular follow-up visits to assess treatment effects and safety.
CONDITIONS
Brief 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 provides written informed consent
- Clinical indication for PCI of chronic total occlusion, such as angina or evidence of ischemia
- Target lesion is a de novo coronary artery
- Angiographically confirmed chronic total occlusion lasting 3 months or more
- Successful guidewire crossing of the CTO lesion during the procedure
- Distal blood flow restored with less than 50% residual narrowing after vessel preparation
- Target vessel diameter between 2.25 mm and 4.0 mm
- Lesion suitable for both drug-coated balloon and drug-eluting stent treatment
- Patient able and willing to comply with study and follow-up requirements
- Female patients of childbearing potential must have a negative pregnancy test and agree to contraception during the study
You will not qualify if you...
- Target CTO lesion is the cause of a recent acute myocardial infarction
- Patient is in cardiogenic shock
- Severe heart failure (NYHA Class IV) or left ventricular ejection fraction below 30%
- Stroke or transient ischemic attack within previous 3 months
- High risk of bleeding or contraindication to dual antiplatelet therapy
- Severe liver or kidney impairment or need for dialysis
- Known allergy to study medications, device materials, or coatings
- Lesion located in unprotected left main artery, saphenous vein graft, or arterial graft
- Severe lesion calcification preventing vessel expansion
- CTO within a previously stented segment
- Failed CTO recanalization attempt
- Complications requiring immediate stent implantation after vessel preparation
- Participation in another interfering interventional trial
- Female patients who are pregnant or breastfeeding
- Investigator judges patient unsuitable for study or compliance issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up treatment lasting at least 12 months
Participants receive either drug-coated balloon angioplasty (with provisional stent if necessary) or drug-eluting stent implantation to treat their coronary chronic total occlusion lesions.
1 procedure visit and regular follow-up visits for up to 36 months
Duration - Up to 36 months post-procedure
Participants are followed up to assess clinical outcomes, including late lumen loss, restenosis rates, cardiac events, and quality of life for up to 36 months after treatment.
Multiple follow-up visits at 6, 9, 12, 24, and 36 months
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
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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