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ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography (ORSIRO_OCT)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ORSIRO
XIENCE PRIME DES
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deutsches Herzzentrum München
  • Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ORSIRO

XIENCE PRIME DES

Arm Description

Outcomes

Primary Outcome Measures

Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment

Secondary Outcome Measures

Full Information

First Posted
May 7, 2012
Last Updated
August 3, 2017
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01594736
Brief Title
ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
Acronym
ORSIRO_OCT
Official Title
Intracoronary Stenting and Angiographic Results: ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORSIRO
Arm Type
Active Comparator
Arm Title
XIENCE PRIME DES
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ORSIRO
Intervention Description
due randomization ORSIRO will be implanted
Intervention Type
Device
Intervention Name(s)
XIENCE PRIME DES
Intervention Description
due randomization XIENCE PRIME DES will be implanted
Primary Outcome Measure Information:
Title
Degree of stent strut coverage at 6 months follow-up assessed by OCT for each visible strut segment
Time Frame
6-18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Joner, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Facility Name
Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

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ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography

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