Coronary Artery DiseaseDCBinT2DMNCT07009938
DCB for CAD With Type 2 Diabetes
A study testing Drug-Coated Balloon (DCB) and Drug-Eluting Stent (DES) implantation in people with Coronary Artery Disease and Diabete Type 2, run by Shanghai 10th People's Hospital at 6 sites in China.
Trial summary
Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabete Type 2
- What is being tested?
- Drug-Coated Balloon (DCB) and Drug-Eluting Stent (DES) implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jul 2025to 1 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosed CAD with ≥70% stenosis in ≥1 coronary artery confirmed by coronary angiography
- Diagnosed type 2 diabetes (per WHO criteria)
- Target lesion suitable for DCB (diameter 2.0-4.0 mm, length ≤40 mm)
- Informed consent provided
Who cannot join
- Prior coronary artery bypass surgery or PCI with complications
- STEMI within 24 hours
- Severe hepatic/renal dysfunction
- Active bleeding or uncontrolled anticoagulation
- Allergy to DCB components
- Pregnancy or lactation
- Psychiatric conditions limiting compliance
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Huaihe Hospital of Henan University
Kaifeng, Henan
Ruili He, MD
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan
Ninghai First Hospital
Ningbo, Zhejiang
Keqiang Lin, MD
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Jiachen Luo, Phd, +8618801790469, messichen@tongji.edu.cn
The Second People's Hospital of Yibin
Yibin, Sichuan
Xuechuan Dan, MD
The First Affiliated Hospital of Zhengzhou Uninversity
Zhengzhou, Henan
Gang Li, PhD, +8618810531058
About this study
Official title: Long-Term Efficacy and Safety of Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease and Type 2 Diabetes: A Multicenter, Prospective, Randomized Controlled Trial
Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.
Read the detailed description
Coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often coexist, and the long-term hyperglycemic state and metabolic disorders in diabetic patients contribute to endothelial dysfunction and accelerated atherosclerosis. As a result, coronary lesions in T2DM patients tend to be more diffuse and complex, posing greater challenges to percutaneous coronary intervention (PCI). Although drug-eluting stents (DES) have significantly improved clinical outcomes, diabetic patients remain at higher risk for in-stent restenosis (ISR) and target lesion revascularization (TLR), negatively impacting long-term prognosis.
Drug-coated balloons (DCBs), a novel PCI technique, allow for rapid and effective delivery of anti-proliferative agents (e.g. paclitaxel or sirolimus) to the vessel wall without leaving behind a permanent implant. This "leave nothing behind" approach reduces the risk of chronic inflammation and stent-related complications. DCBs have shown promising results in non-diabetic populations, particularly in small vessel disease and bifurcation lesions. However, evidence supporting their use in T2DM patients remains limited, especially from prospective, randomized controlled trials. As such, whether DCBs can serve as a viable alternative to DES in this high-risk group remains an open question.
This study aims to evaluate the efficacy and safety of DCB angioplasty in patients with CAD and T2DM through a prospective, randomized controlled design. The study will focus on restenosis rates, improvement in angina symptoms, incidence of major adverse cardiovascular events (MACE), and patient-reported quality of life outcomes, providing a more individualized and evidence-based treatment approach for this challenging patient population.
- Conditions
- Coronary Artery Disease, Diabete Type 2
- Being tested
- Drug-Coated Balloon (DCB), Drug-Eluting Stent (DES) implantation
- Keywords
- coronary artery disease; type 2 diabetes mellitus; drug-coated balloon; target lesion revascularization; major adverse cardiac events
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated Balloon (DCB)Device
Following lesion preparation (usually with a standard balloon), a drug-coated balloon is advanced to the target lesion. The balloon is inflated and maintained to allow effective drug transfer to the vessel wall.
Drug-Eluting Stent (DES) implantationDevice
After coronary angiography identifies the target lesion, a DES is selected based on the vessel size. Post-deployment angiography is performed to confirm the result and check for complications.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention using Drug-Coated Balloon (DCB) | Experimental | Percutaneous coronary intervention using Drug-Coated Balloon (DCB) Receives: Device: Drug-Coated Balloon (DCB) |
| Either Drug-Eluting Stent (DES) implantation group | Active comparator | Percutaneous coronary intervention using Drug-Eluting Stent (DES) implantation Receives: Device: Drug-Eluting Stent (DES) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Diameter Stenosis Rate
Target Lesion Diameter Stenosis Rate refers to the percentage of narrowing at the target coronary lesion, calculated by comparing the minimal lumen diameter (MLD) at the lesion site with the reference vessel diameter (RVD), which was measured based on coronary angiography.
Measured: At 12 months after intervention
Secondary outcomes (4)
Major Adverse Cardiovascular Events (MACE)
A composite of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis)
Measured: At 12 months after intervention
Angina Symptom Improvement
Measured by Seattle Angina Questionnaire (SAQ) at baseline, 1, 3, and 6 months.
Measured: At baseline, 1, 3, 6 and 12 months after intervention
Changes in glycemic indices including glycated hemoglobin (HbA1c)
Changes in glycemic indices including glycated hemoglobin (HbA1c)
Measured: At 3, 6 and 12 months after intervention
Glycemic indices
Changes in fasting blood glucose, and 2-hour postprandial blood glucose levels
Measured: At 3, 6 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yidong Wei, PhD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009938
- Sponsor's protocol ID
- DCBinT2DM
- Acronym
- DCBinT2DM
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Efficacy and Safety of Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease and Type 2 Diabetes: A Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07009938
- Acronym / sponsor ID
- DCBinT2DM / DCBinT2DM
- Conditions
- Coronary Artery Disease, Diabete Type 2
- Keywords
- coronary artery disease; type 2 diabetes mellitus; drug-coated balloon; target lesion revascularization; major adverse cardiac events
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 Jun 2025 (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.
Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.
Detailed description
Coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often coexist, and the long-term hyperglycemic state and metabolic disorders in diabetic patients contribute to endothelial dysfunction and accelerated atherosclerosis. As a result, coronary lesions in T2DM patients tend to be more diffuse and complex, posing greater challenges to percutaneous coronary intervention (PCI). Although drug-eluting stents (DES) have significantly improved clinical outcomes, diabetic patients remain at higher risk for in-stent restenosis (ISR) and target lesion revascularization (TLR), negatively impacting long-term prognosis.
Drug-coated balloons (DCBs), a novel PCI technique, allow for rapid and effective delivery of anti-proliferative agents (e.g. paclitaxel or sirolimus) to the vessel wall without leaving behind a permanent implant. This "leave nothing behind" approach reduces the risk of chronic inflammation and stent-related complications. DCBs have shown promising results in non-diabetic populations, particularly in small vessel disease and bifurcation lesions. However, evidence supporting their use in T2DM patients remains limited, especially from prospective, randomized controlled trials. As such, whether DCBs can serve as a viable alternative to DES in this high-risk group remains an open question.
This study aims to evaluate the efficacy and safety of DCB angioplasty in patients with CAD and T2DM through a prospective, randomized controlled design. The study will focus on restenosis rates, improvement in angina symptoms, incidence of major adverse cardiovascular events (MACE), and patient-reported quality of life outcomes, providing a more individualized and evidence-based treatment approach for this challenging patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention using Drug-Coated Balloon (DCB) | Experimental | Device: Drug-Coated Balloon (DCB)Percutaneous coronary intervention using Drug-Coated Balloon (DCB) |
| Either Drug-Eluting Stent (DES) implantation group | Active comparator | Device: Drug-Eluting Stent (DES) implantationPercutaneous coronary intervention using Drug-Eluting Stent (DES) implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosed CAD with ≥70% stenosis in ≥1 coronary artery confirmed by coronary angiography
- Diagnosed type 2 diabetes (per WHO criteria)
- Target lesion suitable for DCB (diameter 2.0-4.0 mm, length ≤40 mm)
- Informed consent provided
Key exclusion criteria (7 listed)
- Prior coronary artery bypass surgery or PCI with complications
- STEMI within 24 hours
- Severe hepatic/renal dysfunction
- Active bleeding or uncontrolled anticoagulation
- Allergy to DCB components
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 |
|---|---|---|
| Drug-Coated Balloon (DCB)Following lesion preparation (usually with a standard balloon), a drug-coated balloon is advanced to the target lesion. The balloon is inflated and maintained to allow effective drug transfer to the vessel wall. | Device | Percutaneous coronary intervention using Drug-Coated Balloon (DCB) |
| Drug-Eluting Stent (DES) implantationAfter coronary angiography identifies the target lesion, a DES is selected based on the vessel size. Post-deployment angiography is performed to confirm the result and check for complications. | Device | Either Drug-Eluting Stent (DES) implantation group |
Primary outcome
Target Lesion Diameter Stenosis Rate
Time frame: At 12 months after intervention
Target Lesion Diameter Stenosis Rate refers to the percentage of narrowing at the target coronary lesion, calculated by comparing the minimal lumen diameter (MLD) at the lesion site with the reference vessel diameter (RVD), which was measured based on coronary angiography.
4 secondary outcomes
Major Adverse Cardiovascular Events (MACE)
Time frame: At 12 months after intervention
Angina Symptom Improvement
Time frame: At baseline, 1, 3, 6 and 12 months after intervention
Changes in glycemic indices including glycated hemoglobin (HbA1c)
Time frame: At 3, 6 and 12 months after intervention
Glycemic indices
Time frame: At 3, 6 and 12 months after intervention
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 8 Jun 2025.
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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.
Yidong Wei, PhD principal investigator
Shanghai 10th People's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Coated Balloon (DCB) and Drug-Eluting Stent (DES) implantation in people with Coronary Artery Disease and Diabete Type 2, run by Shanghai 10th People's Hospital at 6 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Yidong Wei, PhD (+86-18917683409, ywei@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Diameter Stenosis Rate (time frame: At 12 months after intervention). 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 8 Jun 2025.