Coronary Heart DiseasePhase 4ISAR-TEST6NCT01068106
Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents
A Phase 4 study testing Nobori® (Biodegradable polymer limus-eluting stents) and Xience-V® (Permanent polymer limus-eluting stent) in people with Coronary Heart Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Nobori® (Biodegradable polymer limus-eluting stents) and Xience-V® (Permanent polymer limus-eluting stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,010 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2010to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial.
- Patient's inability to fully cooperate with the study protocol.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum Muenchen
Munich, 80636
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munich, 81675
About this study
Official title: Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings
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).
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Nobori® (Biodegradable polymer limus-eluting stents), Xience-V® (Permanent polymer limus-eluting stent)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nobori® (Biodegradable polymer limus-eluting stents)Device
Also called Nobori®, ISAR G2
due randomization biodegradable polymer limus-eluting stents will be implanted
Xience-V® (Permanent polymer limus-eluting stent)Device
Also called Xience-V®
due randomization permanent polymer limus-eluting stent will be implanted
| Study group | Role | What they receive |
|---|---|---|
| BPLES | Active comparator | Biodegradable polymer limus-eluting stents Receives: Device: Nobori® (Biodegradable polymer limus-eluting stents) |
| PPLES | Active comparator | Permanent polymer limus-eluting stent Receives: Device: Xience-V® (Permanent polymer limus-eluting stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.
Measured: 12 months
Secondary outcomes (4)
The composite of all cause mortality or myocardial infarction
Measured: 6-8 months
Stent thrombosis
Measured: 6-8 months
Late luminal loss
Measured: 6-8 months
Binary angiographic restenosis
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,010 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julinda Mehilli, MD, Study chair, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068106
- Sponsor's protocol ID
- GE IDE No. S03010
- Acronym
- ISAR-TEST6
- Status last verified
- May 2012
- First submitted
- 11 Feb 2010
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24579987
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings
- ClinicalTrials.gov ID
- NCT01068106
- Acronym / sponsor ID
- ISAR-TEST6 / GE IDE No. S03010
- Conditions
- Coronary Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,010 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPLES | Active comparator | Device: Nobori® (Biodegradable polymer limus-eluting stents)Biodegradable polymer limus-eluting stents |
| PPLES | Active comparator | Device: Xience-V® (Permanent polymer limus-eluting stent)Permanent polymer limus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nobori® (Biodegradable polymer limus-eluting stents)Also: Nobori®, ISAR G2due randomization biodegradable polymer limus-eluting stents will be implanted | Device | BPLES |
| Xience-V® (Permanent polymer limus-eluting stent)Also: Xience-V®due randomization permanent polymer limus-eluting stent will be implanted | Device | PPLES |
Primary outcome
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.
Time frame: 12 months
4 secondary outcomes
The composite of all cause mortality or myocardial infarction
Time frame: 6-8 months
Stent thrombosis
Time frame: 6-8 months
Late luminal loss
Time frame: 6-8 months
Binary angiographic restenosis
Time frame: 6-8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Derived from this study: PubMed 24579987Piccolo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julinda Mehilli, MD study chair
Deutsches Herzzentrum Muenchen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nobori® (Biodegradable polymer limus-eluting stents) and Xience-V® (Permanent polymer limus-eluting stent) in people with Coronary Heart Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.