ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

Coronary Heart Disease Clinical Trial

— ORSIRO_OCT  

Official title:

Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594736
• Other study ID #: MJ-MRI-ORSIRO_OCT-V3.1
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2012
• Last updated: August 3, 2017
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2017
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• ORSIRO
due randomization ORSIRO will be implanted

Device:
• XIENCE PRIME DES
due randomization XIENCE PRIME DES will be implanted

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich	Bavaria
Germany	Klinikum rechts der Isar	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment		6-18 months