NCT02299011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,341

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

4.9 years

First QC Date

November 17, 2014

Last Update Submit

September 23, 2019

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Keywords

Biomatrix drug eluting stentOrsiro drug eluting stentCoronary artery disease

Outcome Measures

Primary Outcomes (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

    18 months

Secondary Outcomes (17)

  • All death

    18 months

  • All death

    36 months

  • Cardiac death

    18 months

  • Cardiac death

    36 months

  • Target vessel-related MI and all MI

    18 months

  • +12 more secondary outcomes

Study Arms (2)

Orsiro drug eluting stent

EXPERIMENTAL

Orsiro drug eluting stent

Device: Orsiro drug eluting stent

Biomatrix drug eluting stent

ACTIVE COMPARATOR

Biomatrix drug eluting stent

Drug: Biomatrix drug eluting stent

Interventions

Orsiro drug eluting stentDEVICE

Orsiro Hybrid drug eluting stent

Also known as: Orsiro drug eluting stent (Biotronik AG, Bulach, Switzeland)
Orsiro drug eluting stent
Biomatrix drug eluting stentDRUG

Biomatrix Flex drug eluting stent

Also known as: Biomatrix drug eluting stent (Biosensors,Newport Beach,USA)
Biomatrix drug eluting stent

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Universtiy Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 23339805BACKGROUND

  • 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.

    PMID: 40104139DERIVED

  • 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.

    PMID: 36475473DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Interventions

Biosensing Techniques

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Probe TechniquesInvestigative Techniques

Study Officials

  • In-Ho Chae, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 24, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

KR(1)