Chronic Total Occlusions of Coronary ArteriesDCB-CTONCT07463664
Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions
A study testing DES Implantation and DCB Angioplasty in people with Chronic Total Occlusions of Coronary Arteries and Chronic Total Occlusion (CTO), run by The First Affiliated Hospital of Zhengzhou University at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Total Occlusions of Coronary Arteries, Chronic Total Occlusion (CTO), Coronary Artery Disease (CAD)
- What is being tested?
- DES Implantation and DCB Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 18 sitesChina
- Study dates
- 28 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Anyang District Hospital
Anyang, Henan, 455000
Yongcun Hu, +86 13598130938, cunhuyong@126.com
Yongcun Hu
- Not yet recruiting
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, 100037
Ru Liu, +86 15901098523, liuru@fuwaihospital.org
Ru Liu
- Not yet recruiting
The People's Hospital of Jiaozuo
Jiaozuo, Henan, 454002
Haijun Zheng, +86 13938150080, jzsrmyyhj@163.com
Haijun Zheng
- Recruiting
Jincheng People's Hospital
Jincheng, Shanxi, 048026
Sancong Pan, Doctor, +86 13753663616, psc456789@163.com
Sancong Pan, Doctor
- Recruiting
The second people's Hospital of Jiyuan
Jiyuan, Henan, 454000
Ruilu Xue, +86 13569118879, xuerl888@sohu.com
Runlu Xue
- Recruiting
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
Xiaoming Zhong, +86 13503783659, zxm10020202@126.com
Xiaoming Zhong
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan, 475000
Jieyun Liu, +86 13803786051, ljy6051@126.com
Jieyun Liu
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Zhijuan Li, +86 13838836086, 13838836086@126.com
Zhijuan Li
- Not yet recruiting
Nanyang City Center Hospital
Nanyang, Henan, 473000
Zhiliang Zhang, +86 18736560527, 18736560527@qq.com
Zhiliang Zhang
- Recruiting
The Second People's Hospital of Pingdingshan
Pingdingshan, Henan, 467000
Ling Zhang, +86 15537591366, zlpds@163.com
Ling Zhang
- Recruiting
Puyang People's Hospital
Puyang, Henan, 457099
Wenyuan Wang, +86 13693930161, wangwenyuan@163.com
Wenyuan Wang
- Not yet recruiting
Yellow River Sanmenxia hospital
Sanmenxia, Henan, 472000
Chaohong Zhang, +86 13803981169, 13803981169@126.com
Chaohong Zhang
- Not yet recruiting
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, 300074
Shangyu Wen, +86 13704676597, liyonghuitj@163.com
Shangyu Wen
- Not yet recruiting
Xinyang Central Hospital
Xinyang, Henan, 464000
Tan Xu, +86 18539258144, 18539258144@163.com
Tan Xu
- Not yet recruiting
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, 450000
Minghua Luo, +86 15837199858, lmhuaaaa@163.com
Minghua Luo
- Not yet recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
Dan Wang, +86 13525531530, wangdan1762@126.com
Dan Wang
- Not yet recruiting
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450053
Dongyu Wan, +86 15238356077, 893592650@qq.com
Dongyu Wan
- Recruiting
Zhoukou Central Hospital
Zhoukou, Henan, 466000
Guoli Jia, +86 13592265990, yanhuaz@sina.com
Guoli Jia
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Total Occlusions of Coronary Arteries, Chronic Total Occlusion (CTO), Coronary Artery Disease (CAD)
- Being tested
- DES Implantation, DCB Angioplasty
- Keywords
- drug-coated balloon, Coronary artery disease, chronic total occlusion, drug-eluting stent, clinical outcome
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DES ImplantationProcedure or surgery
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.
DCB AngioplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DCB Group | Experimental | DCB-only angioplasty or hybrid strategy combining DCB and DES (DCB+DES hybrid approach) Receives: Procedure: DCB Angioplasty |
| DES-only Group | Active comparator | underwent Implantation with Drug-Eluting Stent-only Receives: Procedure: DES Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 months
Secondary outcomes (7)
In-segment Binary Restenosis / Re-occlusion Rate
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.
Measured: 9 months
Target Lesion Failure, TLF
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).
Measured: 12 month (primary clinical assessment), 24 months, 36 months
Cardiac Death
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.
Measured: 12 month, 24 months, 36 months
Clinically Driven Target Lesion Revascularization (CD-TLR)
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.
Measured: 12 month, 24 months, 36 months
Target Vessel Myocardial Infarction (TV-MI)
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).
Measured: 12 month, 24 months, 36 months
Very Late Clinical Events
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.
Measured: 24个月、36个月
Angina Status Change (CCS Grading or SAQ Score Change)
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.
Measured: Baseline vs. 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start28 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusions of Coronary ArteriesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunguang Qiu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Chunguang Qiu, Doctor, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463664
- Sponsor's protocol ID
- 2024-KY-1551-002
- Other IDs
- LHGJ20230176
- Acronym
- DCB-CTO
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Drug-Coated Balloons in the Treatment of Patients With Coronary De Novo Chronic Total Occlusion Lesions: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07463664
- Acronym / sponsor ID
- DCB-CTO / 2024-KY-1551-002
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB Group | Experimental | Procedure: DCB AngioplastyDCB-only angioplasty or hybrid strategy combining DCB and DES (DCB+DES hybrid approach) |
| DES-only Group | Active comparator | Procedure: DES Implantationunderwent Implantation with Drug-Eluting Stent-only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DES ImplantationDrug-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. | Procedure or surgery | DES-only Group |
| DCB AngioplastyDrug-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. | Procedure or surgery | DCB Group |
Primary outcome
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).
7 secondary outcomes
In-segment Binary Restenosis / Re-occlusion Rate
Time frame: 9 months
Target Lesion Failure, TLF
Time frame: 12 month (primary clinical assessment), 24 months, 36 months
Cardiac Death
Time frame: 12 month, 24 months, 36 months
Clinically Driven Target Lesion Revascularization (CD-TLR)
Time frame: 12 month, 24 months, 36 months
Target Vessel Myocardial Infarction (TV-MI)
Time frame: 12 month, 24 months, 36 months
Very Late Clinical Events
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunguang Qiu, Doctor study chair
The First Affiliated Hospital of Zhengzhou University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DES Implantation and DCB Angioplasty in people with Chronic Total Occlusions of Coronary Arteries and Chronic Total Occlusion (CTO), run by The First Affiliated Hospital of Zhengzhou University at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Pan, Doctor (+86-15003851743, huzhoupanliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment Late Lumen Loss, LLL (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.