ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Collaborator: Technische Universität München

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