Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents (ISAR-TEST6)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Nobori® (Biodegradable polymer limus-eluting stents)
Xience-V® (Permanent polymer limus-eluting stent)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
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.
Exclusion Criteria:
- Target lesion located in the left main trunk.
- In-stent restenosis of DES.
- Cardiogenic shock.
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome.
- Inability to take dual antiplatelet therapy for at least 6 months.
- 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 Muenchen
- Klinikum rechts der Isar der Technischen Universitaet Muenchen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BPLES
PPLES
Arm Description
Biodegradable polymer limus-eluting stents
Permanent polymer limus-eluting stent
Outcomes
Primary Outcome Measures
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.
Secondary Outcome Measures
The composite of all cause mortality or myocardial infarction
Stent thrombosis
Late luminal loss
Binary angiographic restenosis
Full Information
NCT ID
NCT01068106
First Posted
February 11, 2010
Last Updated
May 7, 2012
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT01068106
Brief Title
Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents
Acronym
ISAR-TEST6
Official Title
Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).
Detailed Description
Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs - rapamycin, everolimus and biolimus - are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.
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
2010 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BPLES
Arm Type
Active Comparator
Arm Description
Biodegradable polymer limus-eluting stents
Arm Title
PPLES
Arm Type
Active Comparator
Arm Description
Permanent polymer limus-eluting stent
Intervention Type
Device
Intervention Name(s)
Nobori® (Biodegradable polymer limus-eluting stents)
Other Intervention Name(s)
Nobori®, ISAR G2
Intervention Description
due randomization biodegradable polymer limus-eluting stents will be implanted
Intervention Type
Device
Intervention Name(s)
Xience-V® (Permanent polymer limus-eluting stent)
Other Intervention Name(s)
Xience-V®
Intervention Description
due randomization permanent polymer limus-eluting stent will be implanted
Primary Outcome Measure Information:
Title
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The composite of all cause mortality or myocardial infarction
Time Frame
6-8 months
Title
Stent thrombosis
Time Frame
6-8 months
Title
Late luminal loss
Time Frame
6-8 months
Title
Binary angiographic restenosis
Time Frame
6-8 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.
Exclusion Criteria:
Target lesion located in the left main trunk.
In-stent restenosis of DES.
Cardiogenic shock.
Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome.
Inability to take dual antiplatelet therapy for at least 6 months.
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
Julinda Mehilli, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitaet Muenchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24579987
Citation
Piccolo R, Nicolino A, Danzi GB. The Nobori biolimus-eluting stent: update of available evidence. Expert Rev Med Devices. 2014 May;11(3):275-82. doi: 10.1586/17434440.2014.894458. Epub 2014 Mar 3.
Results Reference
derived
Learn more about this trial
Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents
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