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Coronary Artery DiseaseNCT05200637

Vascular Response of Orsiro vs. Xience Drug-Eluting Stents for Treating Coronary Bifurcation Lesions

A study testing Orsiro stent, Xience stent and Any drug-eluting stent in people with Coronary Artery Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Orsiro stent, Xience stent and Any drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTaiwan
Study dates
1 Feb 2022to 31 Dec 2024
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are at least 20 years old and present with acute or chronic coronary syndrome.
  • Patients who are suitable for PCI with DES implantation and provide written informed consent.
  • Patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (DK) crush technique.
  • Target vessels suitable for OCT examination.
  • Women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.

Who cannot join

  • Patient who are not suitable candidates for use of dual antiplatelet therapy (DAPT)
  • Estimated glomerular filtration rate < 45 ml/min/1.73 m2
  • Liver cirrhosis
  • Life expectancy < 1 year
  • Planned surgery within 3 months
  • Pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months
  • Target bifurcation lesion involved in chronic total occlusion or the culprit vessel of ST-elevation myocardial infarction

Trial locations and contacts

1 site in 1 country.

Ying-Chang Tung, MD contact

886-3-3281200 ext. 8162

n12374@cgmh.org.tw

Chi-Jen Chang, MD contact

886-3-3281200 ext. 8162

chijenformosa@gmail.com

Taiwan1 site

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Randomized, Parallel, Active Controlled Study to Evaluate the Vascular Response of Orsiro vs. Xience Drug Eluting Stent System in Subjects With Coronary Bifurcation Lesions

This study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (Orsiro, Biotronik) and a durable-polymer, thin-strut, drug-eluting stent (Xience, Abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. How the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.

Read the detailed description

Patients with true coronary bifurcation lesions (Medina [1, 1, 1] or [0, 1, 1]) will be enrolled and randomized to undergo two-stent double kissing crush technique with Orsiro or Xience. Pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. All subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.

Being tested
Orsiro stent, Xience stent, Any drug-eluting stent
Keywords
Drug-eluting stents, Coronary bifurcation lesions, Double-kissing crush technique, Optical coherence tomography
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.

  • Orsiro stentDevice

    Orsiro stent

  • Xience stentDevice

    Xience stent

  • Any drug-eluting stentDevice

    Any drug-eluting stent

Study groups in NCT05200637
Study groupRoleWhat they receive
OrsiroActive comparatorTwo-stent DK-crush technique with Orsiro
Receives: Device: Orsiro stent
XienceActive comparatorTwo-stent DK-crush technique with Xience
Receives: Device: Xience stent
Single stentOtherProvisional one-stent strategy with any drug-eluting stent
Receives: Device: Any drug-eluting stent

What is being measured

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

  1. Percentage of stent strut coverage at bifurcation segments

    Measured: 3 months post-procedure

Secondary outcomes (24)

  1. Neointimal thickness (μm) at bifurcation segments

    Measured: 3 months post-procedure

  2. Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments

    Measured: 3 months post-procedure

  3. Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments

    Measured: 3 months post-procedure

  4. Percentage of acquired malapposed struts at bifurcation segments

    Measured: 3 months post-procedure

  5. Percentage of stent strut coverage at bifurcation segments

    Measured: 12 months post-procedure

  6. Neointimal thickness (μm) at bifurcation segments

    Measured: 12 months post-procedure

  7. Amount of in-stent intimal hyperplasia (mm3) at bifurcation segments

    Measured: 12 months post-procedure

  8. Amount of in-segment intimal hyperplasia (mm3) at bifurcation segments

    Measured: 12 months post-procedure

  9. Percentage of acquired malapposed struts at bifurcation segments

    Measured: 12 months post-procedure

  10. In-stent late-lumen loss by quantitative coronary analysis

    Measured: 3 months post-procedure

  11. In-segment late lumen loss by quantitative coronary analysis

    Measured: 3 months post-procedure

  12. Target Lesion Revascularization (TLR)

    Measured: 3 months post-procedure

  13. Target Vessel Revascularization (TVR)

    Measured: 3 months post-procedure

  14. Target Lesion Failure (TLF)

    Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR

    Measured: 3 months post-procedure

  15. Major Cardiac Adverse Events (MACE)

    Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)

    Measured: 3 months post-procedure

  16. Instent late-lumen loss by quantitative coronary analysis

    Measured: 12 months post-procedure

  17. In-segment late lumen loss by quantitative coronary analysis

    Measured: 12 months post-procedure

  18. Target Lesion Revascularization (TLR)

    Measured: 12 months post-procedure

  19. Target Vessel Revascularization (TVR)

    Measured: 12 months post-procedure

  20. Target Lesion Failure (TLF)

    Cardiac death, target vessel related myocardial infarction (MI), and clinically indicated TLR

    Measured: 12 months post-procedure

  21. Major Cardiac Adverse Events (MACE)

    Cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary artery bypass surgery, or target vessel revascularization (TVR)

    Measured: 12 months post-procedure

  22. Stent thrombosis

    Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis

    Measured: 1 months post-procedure

  23. Stent thrombosis

    Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis

    Measured: 3 months post-procedure

  24. Stent thrombosis

    Stent thrombosis (all, definite, definite/probable, probable, possible) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis

    Measured: 12 months post-procedure

Timeline

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

  1. First posted21 Jan 2022
  2. Study start1 Feb 2022 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (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
Model description
Patients with true coronary bifurcation lesions will be randomized to undergo two-stent DK-crush technique with Orsiro or Xience. Another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05200637
Sponsor's protocol ID
202101599A3
Status last verified
Jan 2022
First submitted
4 Jan 2022
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Orsiro stent, Xience stent and Any drug-eluting stent in people with Coronary Artery Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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: status not confirmed, as of the sponsor's last update on 21 Jan 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 Taiwan. 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 Ying-Chang Tung, MD (886-3-3281200 ext. 8162, n12374@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of stent strut coverage at bifurcation segments (time frame: 3 months post-procedure). 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 NCT05200637.

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 21 Jan 2022.

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