Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent

NCT01826552 | Completed Phase 4 DMC

• 1 other identifier: NCT01826552
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this multicenter, randomized, open label, parallel arm study whether the newest 3rd generation stent - Orsiro hybrid sirolimus-eluting stent is noninferior to the newest 2nd generation stent - Resolute Integrity zotarolimus-eluting stent in terms of 9 months in-stent late lumen loss. 345 Korean patients with a wide variety of coronary heart disease will be enrolled to this "all-comers" trial to give definite answer to the above hypothesis that is urgently needed.

Conditions

Coronary Artery Disease; Coronary Heart Disease; Stable Angina; Unstable Angina; ST-segment Elevation Myocardial Infarction; Non-ST-segment Elevation Myocardial Infarction

Keywords

Orsiro hybrid stent; Drug-eluting stent; Zotarolimus-eluting stent; Coronary heart disease; Cobalt chromium

Outcome Measures

Primary Outcomes (1)

• Late lumen loss (in-stent)

  Difference between the postprocedure and 9-month follow-up in-stent minimum lumen diameter. All QCA measurements of the target lesion will be obtained in the in-stent zone, and over entire segment including the stent and its 5 mm proximal and distal margins (in-segment zone).

  at 9 months

Secondary Outcomes (16)

• All-cause death

  at 12 months

• Cardiac death

  at 12 months

• Target lesion revascularization

  at 12 months

• Target vessel revascularization

  at 12 months

• Target-vessel related myocardial infarction

  at 12 months

Study Arms (2)

Orsiro

EXPERIMENTAL

The Patient group who are treated with Osiro Hybrid Drug-Eluting Stent (Biotronik AG, Bulach, Switzeland)

Device: Osiro Hybrid Drug-Eluting Stent

Resolute Integrity

ACTIVE COMPARATOR

The Patient group who are treated with ② Resolute Integrity zotarolimus-eluting stent (Medtronic Cardiovascular, CA, Minnesota, USA)

Device: Resolute Integrity

Interventions

Osiro Hybrid Drug-Eluting Stent DEVICE

Osiro Hybrid Drug-Eluting Stent (Biotronik AG, Bulach, Switzeland)

Orsiro

Resolute Integrity DEVICE

Resolute Integrity zotarolimus-eluting stent (Medtronic Cardiovascular, CA, Minnesota, USA)

Resolute Integrity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 Orsiro Hybrid DES® or Endeavor Resolute Integrity® stent.
• He/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, acute myocardial infarction, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia) with a coronary artery or graft vessel lesion with \>50% stenosis by visual estimation or \>70% stenosis irrespective of the functional status.
• Target lesion(s) must be located in a coronary artery with estimated reference diameter of ≥ 2.5 mm and ≤ 5.0 mm.
• Target lesion(s) must be amenable for PCI.

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Sirolimus, Zotarolimus, Cobalt chromium, 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.)
• Patients who cannot maintain aspirin, plavix from the study enrollment to study completion (during 1 year).
• Systemic (intravenous) Sirolimus or Zotarolimus 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 or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• Planned major non-cardiac surgery within the study period.
• Patients in cardiogenic shock
• Patients with symptomatic heart failure that preclude coronary angiography in supine position.
• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Jeju National University Hospital: collaborator
• Chungbuk National University Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Korea University: collaborator
• Inje University: collaborator
• Kyung Hee University Hospital at Gangdong: collaborator
• Inha University Hospital: collaborator

Study Sites (8)

Korea University Ansan Hospital

Ansan, South Korea

Location

Chungbuk University Hospital

Cheongju-si, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Jeju University Hospital

Jeju City, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Boramae Medical Center

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong Hospital

Seoul, South Korea

Location

Related Publications (1)

• Lee JM, Park SD, Lim SY, Doh JH, Cho JM, Kim KS, Bae JW, Chung WY, Youn TJ. Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial. Trials. 2013 Nov 20;14:398. doi: 10.1186/1745-6215-14-398.

  PMID: 24257456 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Angina, Stable; Angina, Unstable; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Tae-Jin Youn, MD,PhD

  Division of Cardiology, Department of Internal Medicine, College of Medicine, Seoul National University and Cardiovascular Center, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Dong-Ju Choi, MD,PhD

  Division of Cardiology, Department of Internal Medicine and Cardiovascular Center, Seoul National University Bundang Hospital

  STUDY CHAIR

• In-Ho Chae, MD,PhD

  Division of Cardiology, Department of Internal Medicine and Cardiovascular Center, Seoul National University Bundang Hospital

  STUDY DIRECTOR

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: Professor

Study Record Dates

• First Submitted: March 3, 2013
• First Posted: April 8, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (8)