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Acute ST-segment Elevation Myocardial InfarctionNCT05680051

DCB Under the Guidance of OCT in STEMI

A study testing Drug-eluting balloon and Drug-eluting stent in people with Acute ST-segment Elevation Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute ST segment elevation myocardial infarction (STEMI) has a high disability mortality rate, and timely reperfusion treatment can significantly reduce the mortality of patients. Emergency PCI is the preferred strategy for STEMI treatment recommended by domestic and international guidelines. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Drug-eluting balloon and Drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
30 Jan 2023to 28 Feb 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75
  • Definitely diagnosed as acute ST segment elevation myocardial infarction according to diagnostic criteria
  • Time of onset ≤ 12h
  • Voluntary signing of informed consent
  • After pretreatment, the culprit vessel participates in stenosis ≤ 30%, no type C (or OCT shows that the dissection involves the middle membrane, and the angle is ≥ 90 degrees) or above, no hematoma, and no obvious thrombus (TIMI thrombus load rating ≤ 2)

Who cannot join

  • Time of onset>12h
  • Those who are allergic to contrast agents, aspirin tablets and Tigrilol tablets;
  • Active bleeding or recent bleeding history
  • Cardiogenic shock and long-term cardiopulmonary resuscitation;
  • The life span is expected to be less than 12 months
  • Angiography showed left main trunk lesion;
Show all 12Show fewer
  • Angiography shows patients with in stent restenosis
  • Patients who the investigator thinks may affect the normal progress of the study or cannot cooperate well with the study or may cause obvious risks, such as alcoholics or drug abusers, cancer, serious liver, kidney, lung, endocrine (such as uncontrolled diabetes or thyroid disease), nervous or blood system diseases;
  • Known or suspected pregnancy (baseline ß - hCG pregnancy test must be conducted for women in childbearing period), women in menstrual period.
  • The criminal blood vessel has C-type or above dissection after pretreatment, and there is coronary hematoma.
  • After pretreatment, criminal vessels still have obvious thrombus residues (TIMI thrombus load grade ≥ 3)
  • OCT confirms that the criminal lesion is caused by plaque erosion

Trial locations and contacts

1 site in 1 country.

Junhui Zhang, Dr contact

+86 0371 58681033

09junhuizhang@163.com

China1 site, 1 recruiting

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 450000

    Junhui Zhang, Dr, 0371 58681033, 09junhuizhang@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-center, Randomized, Parallel Controlled Clinical Trial of Drug Coated Balloon Under the Guidance of OCT in the Treatment of Acute ST-segment Elevation Myocardial Infarction

Acute ST segment elevation myocardial infarction (STEMI) has a high disability mortality rate, and timely reperfusion treatment can significantly reduce the mortality of patients. Emergency PCI is the preferred strategy for STEMI treatment recommended by domestic and international guidelines. The long-term existence of stents can never completely avoid the formation of thrombosis in the stents and affect the relaxation and contraction of criminal blood vessels. Drug coated balloon provides a new concept and technology of interventional therapy for coronary artery disease in the form of "intervention without implantation". Through balloon dilation of local blood vessels to release anti proliferative drugs to coronary artery wall and inhibit intimal hyperplasia, it can not only treat serious coronary artery disease, improve coronary blood supply and vascular function, but also not leave permanent implants in the blood vessels; The main pathogenesis of STEMI is thrombosis based on the rupture or erosion of coronary atheromatous plaque. In terms of pathophysiological mechanism, drug coated balloons are also suitable for STEMI patients without obvious thrombosis or severe dissection after full pretreatment. The two-dimensional lumen images obtained by traditional coronary angiography can not directly reflect the vessel wall, so we can not evaluate the actual size of the vessel, plaque characteristics and the effect of intervention through coronary angiography; Optical coherence tomography (OCT) uses near-infrared scanning to produce high-resolution tissue microscopic images with a resolution of up to 10 μ m. It can clearly observe the three-layer structure of coronary artery, find abnormal intima structure, and more clearly identify thrombosis, dissection, plaque erosion or collapse in coronary artery, providing more valuable information for optimizing interventional treatment. Therefore, the application of drug coated balloon under the guidance of OCT in STEMI can provide a more accurate and optimized diagnosis and treatment scheme for STEMI patients.

Being tested
Drug-eluting balloon, Drug-eluting stent
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.

  • Drug-eluting balloonDevice

    Drug eluting balloon was used in the experimental group

  • Drug-eluting stentDevice

    Drug eluting stent was used in the control group

Study groups in NCT05680051
Study groupRoleWhat they receive
Experimental groupExperimentalDrug-coated Balloon (Lepu Medical Technology (Beijing) Co.,Ltd.)
Receives: Device: Drug-eluting balloon
Control groupActive comparatorDrug Eluting Stent(Microport Medical)
Receives: Device: Drug-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late lumen loss rate

    Measured: 10 months after discharge.

Secondary outcomes (8)

  1. Revascularization rate of target lesions

    Measured: 10 months after discharge.

  2. Target vessel revascularization rate

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

  3. Major Adverse Cardiovascular Events

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

  4. Cardiovascular death

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

  5. Recurrent acute myocardial infarction

    Time-to-onset for recurrent acute myocardial infarction, as ascertained according to follow-up

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

  6. Stroke

    Time-to-onset for stroke, as ascertained according to follow-up

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

  7. All cause of death

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

  8. Unstable angina

    Time-to-onset for unstable angina, as ascertained according to follow-up

    Measured: 1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start30 Jan 2023
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680051
Sponsor's protocol ID
HenanICE202208
Status last verified
Mar 2023
First submitted
14 Dec 2022
Last updated
24 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Drug-eluting balloon and Drug-eluting stent in people with Acute ST-segment Elevation Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology 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 5 inclusion and 12 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 24 Mar 2023. 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. 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 Junhui Zhang, Dr (+86 0371 58681033, 09junhuizhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late lumen loss rate (time frame: 10 months after discharge.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05680051.

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 24 Mar 2023.

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