Arteriosclerosis of Arterial Coronary Artery Bypass GraftPhase 4ISAR-CABGNCT00611910
Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions
A Phase 4 study testing sirolimus-eluting stent, paclitaxel-eluting stent and biodegradable-polymer-based sirolimus-eluting stent in people with Arteriosclerosis of Arterial Coronary Artery Bypass Graft, run by Deutsches Herzzentrum Muenchen at 4 sites in Germany.
Trial summary
The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis of Arterial Coronary Artery Bypass Graft
- What is being tested?
- sirolimus-eluting stent, paclitaxel-eluting stent and biodegradable-polymer-based sirolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 2007to Mar 2011
- 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% de novo stenosis located in CABG
- 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
- Cardiogenic shock
- Target lesion located in the native coronary vessels.
- In-stent restenosis of CABG
- Target lesion located at internal mammary artery graft or free arterial graft
- 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: clopidogrel, rapamycin, paclitaxel, stainless steel.
Show all 10Show fewer
- Inability to take clopidogrel 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.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Herzzentrum Bad Krozingen
Bad Krozingen
Bad Segeberger Kliniken
Bad Segeberg
Medizinische Klinik, Klinikum rechts der Isar
München, 81675
Deutsches Herzzentrum Muenchen
Munich, 80636
About this study
Official title: Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.
The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting
Read the detailed description
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. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.
- Being tested
- sirolimus-eluting stent, paclitaxel-eluting stent, biodegradable-polymer-based sirolimus-eluting stent, bare metal stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus-eluting stentDevice
Also called Cypher
due to randomization Cypher stent will be implanted
paclitaxel-eluting stentDevice
Also called Taxus
due to randomization Taxus stent will be implanted
biodegradable-polymer-based sirolimus-eluting stentDevice
Also called ISAR-DES, Yukon PC
due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
bare metal stentsDevice
Also called Multilink Vision, Driver, etc.
Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist
| Study group | Role | What they receive |
|---|---|---|
| DES | Experimental | drug-eluting stents Receives: Device: sirolimus-eluting stent; Device: paclitaxel-eluting stent; Device: biodegradable-polymer-based sirolimus-eluting stent |
| BMS | Active comparator | bare metal stents Receives: Device: bare metal stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation
Measured: 12 months
Secondary outcomes (4)
Myocardial infarction rate
Measured: 12 months
Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.
Measured: 12 months
All cause death
Measured: 12 months
Stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arteriosclerosis of Arterial Coronary Artery Bypass GraftStudies 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
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Julinda Mehilli, MD, Principal investigator, Deutsches Herzzentrum MuenchenAdnan Kastrati, MD, Study chair, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611910
- Sponsor's protocol ID
- GE IDE No. S02707
- Acronym
- ISAR-CABG
- Status last verified
- May 2011
- First submitted
- 10 Jan 2008
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colleran R, Kufner S, Mehilli J, Rosenbeiger C, Schupke S, Hoppmann P, Joner M, Mankerious N, Fusaro M, Cassese S, Abdel-Wahab M, Neumann FJ, Richardt G, Ibrahim T, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-CABG Investigators. Efficacy Over Time With Drug-Eluting Stents in Saphenous Vein Graft Lesions. J Am Coll Cardiol. 2018 May 8;71(18):1973-1982. doi: 10.1016/j.jacc.2018.03.456.
PubMed 29724350Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.
PubMed 21872918
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.
- ClinicalTrials.gov ID
- NCT00611910
- Acronym / sponsor ID
- ISAR-CABG / GE IDE No. S02707
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Feb 2008 (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 study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting
Detailed description
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. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES | Experimental | Device: sirolimus-eluting stent, Device: paclitaxel-eluting stent, Device: biodegradable-polymer-based sirolimus-eluting stentdrug-eluting stents |
| BMS | Active comparator | Device: bare metal stentsbare metal stents |
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% de novo stenosis located in CABG
- 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 (10 listed)
- Cardiogenic shock
- Target lesion located in the native coronary vessels.
- In-stent restenosis of CABG
- Target lesion located at internal mammary artery graft or free arterial graft
- 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.
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 |
|---|---|---|
| sirolimus-eluting stentAlso: Cypherdue to randomization Cypher stent will be implanted | Device | DES |
| paclitaxel-eluting stentAlso: Taxusdue to randomization Taxus stent will be implanted | Device | DES |
| biodegradable-polymer-based sirolimus-eluting stentAlso: ISAR-DES, Yukon PCdue to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted | Device | DES |
| bare metal stentsAlso: Multilink Vision, Driver, etc.Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist | Device | BMS |
Primary outcome
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation
Time frame: 12 months
4 secondary outcomes
Myocardial infarction rate
Time frame: 12 months
Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.
Time frame: 12 months
All cause death
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
- Derived from this study: PubMed 29724350Colleran R, Kufner S, Mehilli J, Rosenbeiger C, Schupke S, Hoppmann P, Joner M, Mankerious N, Fusaro M, Cassese S, Abdel-Wahab M, Neumann FJ, Richardt G, Ibrahim T, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-CABG Investigators. Efficacy Over Time With Drug-Eluting Stents in Saphenous Vein Graft Lesions. J Am Coll Cardiol. 2018 May 8;71(18):1973-1982. doi: 10.1016/j.jacc.2018.03.456.
- Derived from this study: PubMed 21872918Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.
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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 principal investigator
Deutsches Herzzentrum Muenchen
Adnan Kastrati, MD study chair
Deutsches Herzzentrum Muenchen
4 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 sirolimus-eluting stent, paclitaxel-eluting stent and biodegradable-polymer-based sirolimus-eluting stent in people with Arteriosclerosis of Arterial Coronary Artery Bypass Graft, run by Deutsches Herzzentrum Muenchen at 4 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 10 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: finished, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation (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 NCT00611910, which also lists 2 linked publications.
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 13 May 2011.