Diffuse Coronary Artery LesionsNCT03589157
Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial
A study testing drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) and drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) in people with Diffuse Coronary Artery Lesions, run by Chinese PLA General Hospital.
Trial summary
The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Coronary Artery Lesions
- What is being tested?
- drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) and drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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-related
- Patients who have typical angina pectoris symptoms with obvious evidence of ischemia;
- Patients whose ages are between 18-80 years;
- Patients who must agree to receive a 9-month angiographic follow-up;
- Patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months;
- Patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol;
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- Patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent;
- Lesion-related
- Diffuse coronary artery disease in situ;
- Reference target vessel diameter of 2.5-4.0 mm and length of > 25 mm;
- Non-target vessel lesions needing to receive a successful intervention therapy first before randomization to receive treatment for target lesions (note: within the same hospitalization);
- Visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ECT or FFR<0.8)
Who cannot join
- Patient-related:
- Patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week;
- Patients with serious congestive heart failure or NYHA IV-level serious heart failure;
- Patients whose left ventricular ejection fraction is < 30%;
- Patients who have medical history of stroke or TIA within 6 months prior to the surgery;
- Patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography;
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- Patients who have a current or previous history of serious kidney failure (GFR<30 ml/min) and thereby fail to meet the requirements of angiography;
- Patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage;
- Patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically;
- Patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of ADP receptor antagonists;
- Pregnant or lactating women or women who are planning to become pregnant during the study.
- Patients participating in any other clinical trial;
- Patients who are considered not suitable for inclusion by the investigator for any other reason;
- Lesion-related:
- Patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy;
- Patients who have left main coronary artery disease or graft lesions needing to be treated;
- Patients who have bifurcation lesions with a side-branch vessel diameter of >2.5 mm;
- Patients who have lesions at the ostia of coronary artery, at the circumflex branch, at the ostia of anterior descending branch or within 5 mm at the ostia of coronary artery;
- Severe intimal tear disease;
- In-stent restenosis;
- Lesions which can not be treated with PTCA or other intervention technologies;
- Lesions with serious calcification;
- Concomitant medication related
- Patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs;
- Patients who can not tolerate Aspirin and/or Clopidogrel, or who have serious hypohepatia and must not use Clopidogrel;
- Patients who can not tolerate or have known allergy to heparin, contrast media, paclitaxel, iopromide, rapamycin, poly(lactic-co-glycolic acid) polymers or stainless steel, etc,;
- Patients with a history of leukopenia (with WBC<3×109/L for more than 3 days), neutropenia (with ANC <1,000 cells/mm3 for more than 3 days), or thrombocytopenia (with platelet count <100,000/mm3);
Trial locations and contacts
No sites are listed yet.
About this study
The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.
- Conditions
- Diffuse Coronary Artery Lesions
- Being tested
- drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES), drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)Device
using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions
drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)Device
using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon group | Experimental | Not described Receives: Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) |
| second-generation drug-eluting stent group | Active comparator | Not described Receives: Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss
Late lumen loss (LLL) in the lesion segment within 9 months after surgery
Measured: 9 months
Secondary outcomes (5)
Interventional therapy success rate
including device success rate, lesion success rate and clinical success rate
Measured: 3 years
Restenosis rate (RR) in the lesion segment
Restenosis rate (RR) in the lesion segment on 9 months after operation
Measured: 9 months
Clinically-driven target lesion revascularization
Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively
Measured: 3 years
Device-related cardiovascular clinical composite endpoints
including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short
Measured: 3 years
Patient-related cardiovascular clinical composite endpoints
including all-cause mortality, all myocardial infarctions, and any revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start15 Jul 2018 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Coronary Artery LesionsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589157
- Sponsor's protocol ID
- AAG-G-H-1518
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 17 Jul 2018
- 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 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03589157
- Acronym / sponsor ID
- AAG-G-H-1518
- Conditions
- Diffuse Coronary Artery Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Jul 2018 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Jul 2018 (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 prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon group | Experimental | Device: drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) |
| second-generation drug-eluting stent group | Active comparator | Device: drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient-related
- Lesion-related
Key exclusion criteria (27 listed)
- Patient-related:
- Lesion-related:
- Concomitant medication related
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) combined with spot stenting of drug-eluting stent (DES)using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions | Device | Drug-coated balloon group |
| drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions | Device | second-generation drug-eluting stent group |
Primary outcome
Late lumen loss
Time frame: 9 months
Late lumen loss (LLL) in the lesion segment within 9 months after surgery
5 secondary outcomes
Interventional therapy success rate
Time frame: 3 years
Restenosis rate (RR) in the lesion segment
Time frame: 9 months
Clinically-driven target lesion revascularization
Time frame: 3 years
Device-related cardiovascular clinical composite endpoints
Time frame: 3 years
Patient-related cardiovascular clinical composite endpoints
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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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. This study is not recruiting at the moment.
Yundai Chen, MD principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) and drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) in people with Diffuse Coronary Artery Lesions, run by Chinese PLA General Hospital.
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 12 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao Lei, MD (13661022415, nkgaolei2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late lumen loss (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 17 Jul 2018.