STEMINCT04475978
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial
A study testing IVUS-guide DCB PTCA and Angio-guide DCB PTCA in people with STEMI, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial summary
Objectives: The present study aimed to investigate the difference in late luminal loss (LLL) at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS) versus angiography for ST-segment elevated myocardial infarction （STEMI）patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI
- What is being tested?
- IVUS-guide DCB PTCA and Angio-guide DCB PTCA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to 30 Mar 2023
- 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
- Acute myocardial infarction eligible for PPCI:
- >20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography) .
- Reperfusion is expected to be feasible within 12 h after onset of complaints.
- Infarct related artery eligible for PPCI and:
- De novo lesion in a native coronary artery
- Reference-vessel diameter 2.5 mm and 4 mm
- Diameter stenosis of >50% (by visual assessment) after thrombus aspiration and pre-dilatation.
Who cannot join
- - Age <18 yr and >85 yr
- History of myocardial infarction
- lesion length > 30m
- Left Main lesion
- Ostial lesion
- None-target vessel need to treat with PCI
Show all 17Show fewer
- Severe calcification
- Severe tortuosity
- Severe angulation
- Cardiogenic shock before pre-dilation or any serious cases can not perform IVUS
- Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor
- Participation in another clinical study, interfering with this protocol Uncertain
- Known intracranial disease (mass, aneurysm, AVM, haemorrhagic CVA, ischemic CVA/TIA <6 months before inclusion or ischemic CVA with permanent neurological deficit) Gastrointestinal/urinary tract
- bleeding <2 months before inclusion Refusal to receive blood transfusion
- Planned major surgery within 6 weeks
- Stent implantation <1 week before inclusion
- Expected mortality from any cause within the next 12 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361000
Bin Wang, Ph.D, +8613400664305, mocw361@163.com
About this study
Objectives: The present study aimed to investigate the difference in late luminal loss (LLL) at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS) versus angiography for ST-segment elevated myocardial infarction （STEMI）patients.
Background: In primary percutaneous coronary intervention for STEMI, DCB angioplasty has proved to be a safe and feasible strategy. Compare with angiography guidance, IVUS-guided PCI significantly improve clinical outcome. With IVUS guidance, STEMI patients undergo DCB angioplasty might have be beneficial results.
Methods: A total of 208 STEMI patients who required DCB treatment were randomly assigned either an IVUS guidance and angiography guidance group. The primary endpoint was late luminal loss at 9-month. Stent thrombosis (ST) was the safety endpoint.
- Conditions
- STEMI
- Being tested
- IVUS-guide DCB PTCA, Angio-guide DCB PTCA
- Keywords
- STEMI, drug-coated balloon, IVUS
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guide DCB PTCADevice
IVUS-guide DCB PTCA
Angio-guide DCB PTCADevice
Angio-guide DCB PTCA
| Study group | Role | What they receive |
|---|---|---|
| IVUS group | Experimental | Not described Receives: Device: IVUS-guide DCB PTCA |
| Angio group | Placebo comparator | Not described Receives: Device: Angio-guide DCB PTCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss（LLL）
late lumen loss（LLL）
Measured: At 9 months follow-up
Secondary outcomes (1)
target lesion failure (TLF)
the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR
Measured: At 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start25 May 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yulin Zhou, Ph.D, Principal investigator, Clinical Trial Center of Xiamen Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475978
- Sponsor's protocol ID
- 2020YLK5
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2020
- Last updated
- 1 Nov 2022
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04475978
- Acronym / sponsor ID
- 2020YLK5
- Conditions
- STEMI
- Keywords
- STEMI, drug-coated balloon, IVUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 17 Jul 2020 (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.
Objectives: The present study aimed to investigate the difference in late luminal loss (LLL) at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS) versus angiography for ST-segment elevated myocardial infarction （STEMI）patients.
Background: In primary percutaneous coronary intervention for STEMI, DCB angioplasty has proved to be a safe and feasible strategy. Compare with angiography guidance, IVUS-guided PCI significantly improve clinical outcome. With IVUS guidance, STEMI patients undergo DCB angioplasty might have be beneficial results.
Methods: A total of 208 STEMI patients who required DCB treatment were randomly assigned either an IVUS guidance and angiography guidance group. The primary endpoint was late luminal loss at 9-month. Stent thrombosis (ST) was the safety endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS group | Experimental | Device: IVUS-guide DCB PTCA |
| Angio group | Placebo comparator | Device: Angio-guide DCB PTCA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute myocardial infarction eligible for PPCI:
- Infarct related artery eligible for PPCI and:
Key exclusion criteria (17 listed)
- - Age <18 yr and >85 yr
- History of myocardial infarction
- lesion length > 30m
- Left Main lesion
- Ostial lesion
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 |
|---|---|---|
| IVUS-guide DCB PTCAIVUS-guide DCB PTCA | Device | IVUS group |
| Angio-guide DCB PTCAAngio-guide DCB PTCA | Device | Angio group |
Primary outcome
late lumen loss（LLL）
Time frame: At 9 months follow-up
late lumen loss（LLL）
1 secondary outcome
target lesion failure (TLF)
Time frame: At 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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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.
Yulin Zhou, Ph.D principal investigator
Clinical Trial Center of Xiamen Cardiovascular Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-guide DCB PTCA and Angio-guide DCB PTCA in people with STEMI, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site 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 7 inclusion and 17 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Xiang Chen, MD (18033997788, Seanchenx@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（LLL） (time frame: At 9 months follow-up). 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 1 Nov 2022.