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Comparison of Biomatrix and Orsiro Drug Eluting Stent (BIODEGRADE)

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ClinicalTrials.gov Identifier: NCT02299011
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Wonju Severance Christian Hospital
Korea University Guro Hospital
Gangnam Severance Hospital
Chungnam National University Hospital
The Catholic University of Korea
Korea University Anam Hospital
Kosin University Gospel Hospital
KangWon National University Hospital
Gachon University Gil Medical Center
Information provided by (Responsible Party):
Chang-Hwan Yoon, Seoul National University Bundang Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Device: Orsiro drug eluting stent Drug: Biomatrix drug eluting stent Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 2014
Actual Primary Completion Date : June 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Orsiro drug eluting stent
Orsiro drug eluting stent
Device: Orsiro drug eluting stent
Orsiro Hybrid drug eluting stent
Other Name: Orsiro drug eluting stent (Biotronik AG, Bulach, Switzeland)

Active Comparator: Biomatrix drug eluting stent
Biomatrix drug eluting stent
Drug: Biomatrix drug eluting stent
Biomatrix Flex drug eluting stent
Other Name: Biomatrix drug eluting stent (Biosensors,Newport Beach,USA)




Primary Outcome Measures :
  1. Target lesion failure (TLF) [ Time Frame: 18 months ]
    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


Secondary Outcome Measures :
  1. All death [ Time Frame: 18 months ]
    All-cause death as measured by percent of participants with adverse events

  2. All death [ Time Frame: 36 months ]
    All-cause death as measured by percent of participants with adverse events

  3. Cardiac death [ Time Frame: 18 months ]
    cardiac death as measured by percent of participants with adverse events

  4. Cardiac death [ Time Frame: 36 months ]
    cardiac death as measured by percent of participants with adverse events

  5. Target vessel-related MI and all MI [ Time Frame: 18 months ]
    Target vessel-related MI and all MI as measured by percent of participants with adverse events subdivided as q wave and non-q wave

  6. Target vessel-related MI and all MI [ Time Frame: 36 months ]
    Target vessel-related MI and all MI as measured by percent of participants with adverse events subdivided as q wave and non-q wave

  7. Stent thrombosis [ Time Frame: 18 months ]
    Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events

  8. Stent thrombosis [ Time Frame: 36 months ]
    Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events

  9. Net clinical outcome including bleeding (major and minor) as measured by percent [ Time Frame: 18 months ]
    Net clinical outcome including bleeding (major and minor) as measured by percent of participants with adverse events

  10. Net clinical outcome including bleeding (major and minor) as measured by percent [ Time Frame: 36 months ]
    Net clinical outcome including bleeding (major and minor) as measured by percent of participants with adverse events

  11. In-stent & In-segment late loss [ Time Frame: 18 months ]
    In-stent & In-segment late loss as measure by post-PCI and F/U QCA

  12. In-stent & In-segment late loss [ Time Frame: 36 months ]
    In-stent & In-segment late loss as measure by post-PCI and F/U QCA

  13. In-stent & In-segment % diameter stenosis [ Time Frame: 18 months ]
    In-stent & In-segment % diameter stenosis as measure by post-PCI and F/U QCA

  14. In-stent & In-segment % diameter stenosis [ Time Frame: 36 months ]
    In-stent & In-segment % diameter stenosis as measure by post-PCI and F/U QCA

  15. Degree of stent strut endothelialization and malapposition on OCT [ Time Frame: 18 months ]
    Degree of stent strut endothelialization and malapposition on OCT as measure by post-PCI and F/U OCT analysis

  16. Degree of stent strut endothelialization and malapposition on OCT [ Time Frame: 36 months ]
    Degree of stent strut endothelialization and malapposition on OCT as measure by post-PCI and F/U OCT analysis

  17. Target lesion failure (TLF) [ Time Frame: 36 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. General Inclusion Criteria

    1. Subject must be at least 18 years of age.
    2. 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.
    3. Subject must have significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts.
    4. 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.
  2. Angiographic Inclusion Criteria

    1. Target lesion(s) must be located in coronary artery, venous or arterial bypass graft with diameter of ≥ 2.5 mm and ≤ 4.5 mm.
    2. Target lesion(s) must be amenable for percutaneous coronary intervention.

Exclusion Criteria:

  1. 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.)
  2. Systemic (intravenous) Biolimus or Sirolimus use within 12 months.
  3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  4. 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
  5. Patients with severe LV systolic dysfunction (LVEF<25%) or cardiogenic shock
  6. Gastrointestinal or genitourinary bleeding within the prior 2 months, or major surgery within 2 months.
  7. 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).
  8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow- up period.
  9. Symptomatic heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299011


Locations
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Korea, Republic of
Seoul National Universtiy Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Wonju Severance Christian Hospital
Korea University Guro Hospital
Gangnam Severance Hospital
Chungnam National University Hospital
The Catholic University of Korea
Korea University Anam Hospital
Kosin University Gospel Hospital
KangWon National University Hospital
Gachon University Gil Medical Center
Investigators
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Principal Investigator: In-Ho Chae, MD Seoul National University Bundang Hospital

Publications:
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Responsible Party: Chang-Hwan Yoon, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02299011     History of Changes
Other Study ID Numbers: B1403-244-002
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Chang-Hwan Yoon, Seoul National University Bundang Hospital:
Biomatrix drug eluting stent
Orsiro drug eluting stent
Coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes