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Coronary Artery DiseasePhase 4BIODEGRADENCT02299011

Comparison of Biomatrix and Orsiro Drug Eluting Stent

A Phase 4 study testing Orsiro drug eluting stent and Biomatrix drug eluting stent in people with Coronary Artery Disease and Myocardial Ischemia, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have biodegradable polymer for the treatment of all-comers' coronary artery diseases. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease, Myocardial Ischemia
What is being tested?
Orsiro drug eluting stent and Biomatrix drug eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,341 participants
Where
1 siteSouth Korea
Study dates
Jul 2014to Sep 2019
Phase
Phase 4
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • Subject must be at least 18 years of age.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the Biomatrix flex stents or Orsiro stents, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • Subject must have significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
  • Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia). In subjects with diameter stenosis > 70%, evidence of myocardial ischemia does not have to be documented.
  • Angiographic Inclusion Criteria
  • Target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.5 mm.
  • Target lesion(s) must be amenable for percutaneous coronary intervention.

Who cannot join

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Cilostazol, Prasugrel, Ticagrelor, Biolimus, Sirolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
  • Systemic (intravenous) Biolimus or Sirolimus use within 12 months.
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  • History of bleeding diathesis, known coagulopathy (including heparin- induced thrombocytopenia), abnormal hemogram (Hb<10g/dL or PLT count <100,000/μL) or will refuse blood transfusions
  • Patients with severe LV systolic dysfunction (LVEF<25%) or cardiogenic shock
  • Gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months.
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  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow- up period.
  • Symptomatic heart failure

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National Universtiy Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

Official title: Comparison of Biomatrix and Orsiro Drug Eluting Stent in Angiographic Result in Patients With All-comer Patients With Coronary Artery Disease : A Multicenter, Randomized, Open Label Study (BIODEGRADE Study)

The primary objective of the BIODEGRADE study is to evaluate clinical efficacy of the Orsiro drug-eluting stent compared with Biomatrix drug-eluting stent, both of which have biodegradable polymer for the treatment of all-comers' coronary artery diseases.

Read the detailed description

The rate of in-stent restenosis after percutaneous coronary intervention (PCI) has decreased since the launching of drug-eluting stents (DES). However, restenosis still remains a problem since PCI is being performed on more complex, calcified, tortuous and tough lesions. Furthermore, there is still a controversy on whether these DES are more thrombogenic than bare metal stent (BMS) because of inflammation related to the polymer coating and delayed vessel healing due to the eluted drug despite of reduced restenosis. Therefore, works aiming to reduce both restenosis and thrombotic event are still on-going in the field of interventional cardiology, and there has been a rush of various third generation DES with "biodegradable polymer". Recently, Orsiro hybrid DES (Biotronik AG, Bulach, Switzeland) has been developed. The Orsiro DES incorporated optimally combined two kind of polymer onto thinner cobalt-chromium backbone (60um) compared with earlier type of DES. The BIOlute® active component is a bioabsorbable polymer matrix combined with an anti-proliferative drug, sirolimus, that is released in a controlled manner leaving only the PROBIO® coated stent in the long-term. The PROBIO® passive coating encapsulates the stent and eliminates interaction between the metal stent and the surrounding tissue. To date, Orsiro stent showed excellent results in terms of late lumen loss at 9 months in first-in-man single arm trial comparing the historical results of other DES (BIOFLOW-I trial), and RCT with non-inferiority design, comparing late lumen loss at 9 months of Orsiro versus everolimus-eluting stent (Xience prime®) is ongoing (BIOFLOW-II trial). However, there have been no trials comparing the Orsiro stent versus the Biomatrix stent (Biosensors Inc, Newport Beach, CA, USA).

This multicenter, randomized, open label, parallel arm study will evaluate whether the innovative newer generation stent, Orsiro hybrid DES, is non-inferior to the third generation stent, Biomatrix stent, in terms of 18 months late lumen loss.

Being tested
Orsiro drug eluting stent, Biomatrix drug eluting stent
Keywords
Biomatrix drug eluting stent, Orsiro drug eluting stent, Coronary artery disease
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orsiro drug eluting stentDevice

    Also called Orsiro drug eluting stent (Biotronik AG, Bulach, Switzeland)

    Orsiro Hybrid drug eluting stent

  • Biomatrix drug eluting stentDrug

    Also called Biomatrix drug eluting stent (Biosensors,Newport Beach,USA)

    Biomatrix Flex drug eluting stent

Study groups in NCT02299011
Study groupRoleWhat they receive
Orsiro drug eluting stentExperimentalOrsiro drug eluting stent
Receives: Device: Orsiro drug eluting stent
Biomatrix drug eluting stentActive comparatorBiomatrix drug eluting stent
Receives: Drug: Biomatrix drug eluting stent

What is being measured

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

  1. Target lesion failure (TLF)

    TLF is a composite of cardiac death, target vessel-related myocardial infarction and ischemia-driven target lesion revascularization as measured by percent of participants with adverse events

    Measured: 18 months

Secondary outcomes (17)

  1. All death

    All-cause death as measured by percent of participants with adverse events

    Measured: 18 months

  2. All death

    All-cause death as measured by percent of participants with adverse events

    Measured: 36 months

  3. Cardiac death

    cardiac death as measured by percent of participants with adverse events

    Measured: 18 months

  4. Cardiac death

    cardiac death as measured by percent of participants with adverse events

    Measured: 36 months

  5. Target vessel-related MI and all MI

    Target vessel-related MI and all MI as measured by percent of participants with adverse events subdivided as q wave and non-q wave

    Measured: 18 months

  6. Target vessel-related MI and all MI

    Target vessel-related MI and all MI as measured by percent of participants with adverse events subdivided as q wave and non-q wave

    Measured: 36 months

  7. Stent thrombosis

    Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events

    Measured: 18 months

  8. Stent thrombosis

    Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events

    Measured: 36 months

  9. Net clinical outcome including bleeding (major and minor) as measured by percent

    Net clinical outcome including bleeding (major and minor) as measured by percent of participants with adverse events

    Measured: 18 months

  10. Net clinical outcome including bleeding (major and minor) as measured by percent

    Net clinical outcome including bleeding (major and minor) as measured by percent of participants with adverse events

    Measured: 36 months

  11. In-stent & In-segment late loss

    In-stent \& In-segment late loss as measure by post-PCI and F/U QCA

    Measured: 18 months

  12. In-stent & In-segment late loss

    In-stent \& In-segment late loss as measure by post-PCI and F/U QCA

    Measured: 36 months

  13. In-stent & In-segment % diameter stenosis

    In-stent \& In-segment % diameter stenosis as measure by post-PCI and F/U QCA

    Measured: 18 months

  14. In-stent & In-segment % diameter stenosis

    In-stent \& In-segment % diameter stenosis as measure by post-PCI and F/U QCA

    Measured: 36 months

  15. Degree of stent strut endothelialization and malapposition on OCT

    Degree of stent strut endothelialization and malapposition on OCT as measure by post-PCI and F/U OCT analysis

    Measured: 18 months

  16. Degree of stent strut endothelialization and malapposition on OCT

    Degree of stent strut endothelialization and malapposition on OCT as measure by post-PCI and F/U OCT analysis

    Measured: 36 months

  17. Target lesion failure (TLF)

    TLF is a composite of cardiac death, target vessel-related myocardial infarction and ischemia-driven target lesion revascularization as measured by percent of participants with adverse events

    Measured: 36 months

Timeline

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

  1. First posted24 Nov 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJun 2019
  4. Study completionSep 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02299011
Sponsor's protocol ID
B1403-244-002
Acronym
BIODEGRADE
Status last verified
Sep 2019
First submitted
17 Nov 2014
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013 Jan 22;8(9):1006-11. doi: 10.4244/EIJV8I9A155.

    PubMed 23339805

  • Kwun JS, Park JJ, Kang SH, Kim SH, Yoon CH, Suh JW, Youn TJ, Cha KS, Lee SH, Hong BK, Rha SW, Kang WC, Chae IH. Interpreting clinical outcomes using different strut thickness in coronary artery disease: insights from vascular imaging analysis. Front Cardiovasc Med. 2025 Mar 4;12:1491607. doi: 10.3389/fcvm.2025.1491607. eCollection 2025.

    PubMed 40104139

  • Yoon CH, Kwun JS, Choi YJ, Park JJ, Kang SH, Kim SH, Suh JW, Youn TJ, Kim MK, Cha KS, Lee SH, Hong BK, Rha SW, Kang WC, Lee JH, Kim SH, Chae IH. BioMatrix Versus Orsiro Stents for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study. Circ Cardiovasc Interv. 2023 Jan;16(1):e012307. doi: 10.1161/CIRCINTERVENTIONS.122.012307. Epub 2022 Dec 7.

    PubMed 36475473

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Orsiro drug eluting stent and Biomatrix drug eluting stent in people with Coronary Artery Disease and Myocardial Ischemia, run by Seoul National University Bundang Hospital at 1 site in South Korea.

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 8 inclusion and 9 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: finished, as of the sponsor's last update on 25 Sep 2019. 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 South Korea. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion failure (TLF) (time frame: 18 months). 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 NCT02299011, which also lists 3 linked publications.

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 25 Sep 2019.

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