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Comparison of Biomatrix and Orsiro Drug Eluting Stent (BIODEGRADE)

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Orsiro drug eluting stent
Biomatrix drug eluting stent
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Biomatrix drug eluting stent, Orsiro drug eluting stent, Coronary artery disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National Universtiy Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Orsiro drug eluting stent

Biomatrix drug eluting stent

Arm Description

Orsiro drug eluting stent

Biomatrix drug eluting stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All death
All-cause death as measured by percent of participants with adverse events
All death
All-cause death as measured by percent of participants with adverse events
Cardiac death
cardiac death as measured by percent of participants with adverse events
Cardiac death
cardiac death as measured by percent of participants with adverse events
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
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
Stent thrombosis
Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events
Stent thrombosis
Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events
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
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
In-stent & In-segment late loss
In-stent & In-segment late loss as measure by post-PCI and F/U QCA
In-stent & In-segment late loss
In-stent & In-segment late loss as measure by post-PCI and F/U QCA
In-stent & In-segment % diameter stenosis
In-stent & In-segment % diameter stenosis as measure by post-PCI and F/U QCA
In-stent & In-segment % diameter stenosis
In-stent & In-segment % diameter stenosis as measure by post-PCI and F/U QCA
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
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
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

Full Information

First Posted
November 17, 2014
Last Updated
September 23, 2019
Sponsor
Seoul National University Bundang Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT02299011
Brief Title
Comparison of Biomatrix and Orsiro Drug Eluting Stent
Acronym
BIODEGRADE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Ischemia
Keywords
Biomatrix drug eluting stent, Orsiro drug eluting stent, Coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2341 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orsiro drug eluting stent
Arm Type
Experimental
Arm Description
Orsiro drug eluting stent
Arm Title
Biomatrix drug eluting stent
Arm Type
Active Comparator
Arm Description
Biomatrix drug eluting stent
Intervention Type
Device
Intervention Name(s)
Orsiro drug eluting stent
Other Intervention Name(s)
Orsiro drug eluting stent (Biotronik AG, Bulach, Switzeland)
Intervention Description
Orsiro Hybrid drug eluting stent
Intervention Type
Drug
Intervention Name(s)
Biomatrix drug eluting stent
Other Intervention Name(s)
Biomatrix drug eluting stent (Biosensors,Newport Beach,USA)
Intervention Description
Biomatrix Flex drug eluting stent
Primary Outcome Measure Information:
Title
Target lesion failure (TLF)
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
All death
Description
All-cause death as measured by percent of participants with adverse events
Time Frame
18 months
Title
All death
Description
All-cause death as measured by percent of participants with adverse events
Time Frame
36 months
Title
Cardiac death
Description
cardiac death as measured by percent of participants with adverse events
Time Frame
18 months
Title
Cardiac death
Description
cardiac death as measured by percent of participants with adverse events
Time Frame
36 months
Title
Target vessel-related MI and all MI
Description
Target vessel-related MI and all MI as measured by percent of participants with adverse events subdivided as q wave and non-q wave
Time Frame
18 months
Title
Target vessel-related MI and all MI
Description
Target vessel-related MI and all MI as measured by percent of participants with adverse events subdivided as q wave and non-q wave
Time Frame
36 months
Title
Stent thrombosis
Description
Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events
Time Frame
18 months
Title
Stent thrombosis
Description
Stent thrombosis (definite/possible/probable) as measured by percent of participants with adverse events
Time Frame
36 months
Title
Net clinical outcome including bleeding (major and minor) as measured by percent
Description
Net clinical outcome including bleeding (major and minor) as measured by percent of participants with adverse events
Time Frame
18 months
Title
Net clinical outcome including bleeding (major and minor) as measured by percent
Description
Net clinical outcome including bleeding (major and minor) as measured by percent of participants with adverse events
Time Frame
36 months
Title
In-stent & In-segment late loss
Description
In-stent & In-segment late loss as measure by post-PCI and F/U QCA
Time Frame
18 months
Title
In-stent & In-segment late loss
Description
In-stent & In-segment late loss as measure by post-PCI and F/U QCA
Time Frame
36 months
Title
In-stent & In-segment % diameter stenosis
Description
In-stent & In-segment % diameter stenosis as measure by post-PCI and F/U QCA
Time Frame
18 months
Title
In-stent & In-segment % diameter stenosis
Description
In-stent & In-segment % diameter stenosis as measure by post-PCI and F/U QCA
Time Frame
36 months
Title
Degree of stent strut endothelialization and malapposition on OCT
Description
Degree of stent strut endothelialization and malapposition on OCT as measure by post-PCI and F/U OCT analysis
Time Frame
18 months
Title
Degree of stent strut endothelialization and malapposition on OCT
Description
Degree of stent strut endothelialization and malapposition on OCT as measure by post-PCI and F/U OCT analysis
Time Frame
36 months
Title
Target lesion failure (TLF)
Description
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
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Ho Chae, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Universtiy Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23339805
Citation
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.
Results Reference
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Comparison of Biomatrix and Orsiro Drug Eluting Stent

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