ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

NCT ID: NCT01594736

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-30

Brief Summary

This prospective, randomized trial will compare the extent of covered stent strut segments by assessed by Optical Coherence Tomography (OCT) of the ORSIRO DES with that of the XIENCE PRIME DES, which is the standard of choice of contemporary drug eluting stents (DES).

Detailed Description

The ORSIRO drug eluting stent exhibits a favourable vascular healing profile from baseline to 6 months assessed by optical coherence tomography (OCT). Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive before the procedure a loading dose of P2Y12 antagonists (clopidogrel, prasugrel or ticagrelor). Eligible patients who do not meet the exclusion criteria and for whom PCI will be considered as the appropriate form of revascularization will be randomly assigned to the ORSIRO or the XIENCE PRIME DES in the relation 1 x ORSIRO: 1 x XIENCE PRIME. All patients will receive periprocedural intravenous aspirin and heparin or bivalirudin. After the intervention patients will receive aspirin indefinitely and P2Y12 antagonists for at least 6 months. The intravascular imaging by OCT will be performed at the 6-8 months follow-up angiography.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ORSIRO

Group Type: ACTIVE_COMPARATOR

ORSIRO

Intervention Type: DRUG

due randomization ORSIRO will be implanted

XIENCE PRIME DES

Group Type: ACTIVE_COMPARATOR

XIENCE PRIME DES

Intervention Type: DEVICE

due randomization XIENCE PRIME DES will be implanted

Interventions

ORSIRO

due randomization ORSIRO will be implanted

Intervention Type: DRUG

XIENCE PRIME DES

due randomization XIENCE PRIME DES will be implanted

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• In women with childbearing potential a negative pregnancy test is mandatory.
• AHA type A, B1 and B2 lesions.

Exclusion Criteria

• Lesion length > 25 mm requiring a stent length > 28 mm
• Target lesion located in the left main trunk.
• In-stent restenosis.
• Acute myocardial infarction
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 18 months or that may result in protocol non-compliance.
• Known allergy to the study medications: sirolimus, everolimus
• Inability to take dual antiplatelet therapy for at least 6 months.
• The presence of bifurcation lesions
• The presence of calcified lesions
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully cooperate with the study protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Joner, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Klinikum rechts der Isar

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

MJ-MRI-ORSIRO_OCT-V3.1

Identifier Type: -

Identifier Source: org_study_id