Stable AnginaPhase 2NCT00263263
RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
A Phase 2 study testing sirolimus-eluting stent and bare metal stent in people with Stable Angina and Unstable Angina, run by Antwerp Cardiovascular Institute Middelheim at 1 site in Belgium.
Trial summary
Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stable Angina, Unstable Angina, Coronary Artery Disease
- What is being tested?
- sirolimus-eluting stent and bare metal stent
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2003to Dec 2005
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85 years-old
- clear signs and/or symptoms of stable or unstable angina or documented silent ischemia
- one or more de-novo target lesions (>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate)
- signed informed consent.
Who cannot join
- Myocardial Infarction within the previous 7 days
- documented left ventricular ejection fraction <25%
- impaired renal function (creatinine >3.0 mg/dl) at the time of treatment
- outflow obstruction of the graft due to distal anastomotic stenosis
- totally occluded Saphenous Vein Graft
- brachytherapy treatment in the index vessel before enrollment
Show all 10Show fewer
- life expectancy less than 12 months
- known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus
- hemorrhagic diatheses
- a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts
Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials.
Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts.
Read more
Design: Double-blind randomized controlled non-industry-sponsored trial.
Setting: A single-center tertiary-care referral hospital.
Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months.
Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).
- Being tested
- sirolimus-eluting stent, bare metal stent
- Medical subject headings
- Angina, Stable, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus-eluting stentDevice
bare metal stentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late loss
Secondary outcomes (9)
in-segment late loss
binary angiographic in-stent restenosis
binary angiographic in-segment restenosis
intravascular-ultrasound-measured neo-intimal hyperplasia volume
death
myocardial infarction
target-lesion revascularization
target-vessel revascularization
stent thrombosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startSep 2003
- Study completionDec 2005
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 Stable AnginaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Antwerp Cardiovascular Institute Middelheim
- Sponsor type
- University, hospital or other
- Investigators
- Paul Vermeersch, MD, Principal investigator, Antwerp Cardiovascular Institute MiddelheimGlenn Vanlangenhove, MD, PhD, Study chair, Antwerp Cardiovascular Institute MiddelheimPierfrancesco Agostoni, MD, Study director, Antwerp Cardiovascular Institute Middelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263263
- Sponsor's protocol ID
- INCUBATE-001
- Status last verified
- Mar 2007
- First submitted
- 7 Dec 2005
- Last updated
- 14 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G; DELAYED RRISC (Death and Events at Long-term follow-up AnalYsis: Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent) Investigators. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol. 2007 Jul 17;50(3):261-7. doi: 10.1016/j.jacc.2007.05.010. Epub 2007 Jun 13.
PubMed 17631219Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Bruining N, Van den Branden F, Van Langenhove G. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2423-31. doi: 10.1016/j.jacc.2006.09.021. Epub 2006 Nov 28.
PubMed 17174178
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts
- ClinicalTrials.gov ID
- NCT00263263
- Acronym / sponsor ID
- INCUBATE-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Antwerp Cardiovascular Institute MiddelheimUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Dec 2005
- First posted
- 8 Dec 2005 (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.
Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials.
Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts.
Design: Double-blind randomized controlled non-industry-sponsored trial.
Setting: A single-center tertiary-care referral hospital.
Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months.
Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 85 years-old
- clear signs and/or symptoms of stable or unstable angina or documented silent ischemia
- one or more de-novo target lesions (>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate)
- signed informed consent.
Key exclusion criteria (10 listed)
- Myocardial Infarction within the previous 7 days
- documented left ventricular ejection fraction <25%
- impaired renal function (creatinine >3.0 mg/dl) at the time of treatment
- outflow obstruction of the graft due to distal anastomotic stenosis
- totally occluded Saphenous Vein Graft
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 stent | Device | – |
| bare metal stent | Device | – |
Primary outcome
In-stent late loss
9 secondary outcomes
in-segment late loss
binary angiographic in-stent restenosis
binary angiographic in-segment restenosis
intravascular-ultrasound-measured neo-intimal hyperplasia volume
death
myocardial infarction
target-lesion revascularization
target-vessel revascularization
stent thrombosis
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 14 Mar 2007.
- Derived from this study: PubMed 17631219Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Van den Branden F, Van Langenhove G; DELAYED RRISC (Death and Events at Long-term follow-up AnalYsis: Extended Duration of the Reduction of Restenosis In Saphenous vein grafts with Cypher stent) Investigators. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol. 2007 Jul 17;50(3):261-7. doi: 10.1016/j.jacc.2007.05.010. Epub 2007 Jun 13.
- Derived from this study: PubMed 17174178Vermeersch P, Agostoni P, Verheye S, Van den Heuvel P, Convens C, Bruining N, Van den Branden F, Van Langenhove G. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2423-31. doi: 10.1016/j.jacc.2006.09.021. Epub 2006 Nov 28.
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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.
Paul Vermeersch, MD principal investigator
Antwerp Cardiovascular Institute Middelheim
Glenn Vanlangenhove, MD, PhD study chair
Antwerp Cardiovascular Institute Middelheim
Pierfrancesco Agostoni, MD study director
Antwerp Cardiovascular Institute Middelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sirolimus-eluting stent and bare metal stent in people with Stable Angina and Unstable Angina, run by Antwerp Cardiovascular Institute Middelheim at 1 site in Belgium.
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 4 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 14 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
In-stent late loss. 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 NCT00263263, 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 14 Mar 2007.