Ischaemic Heart DiseaseNCT00151658
Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
A study testing Coronary Drug Eluting Stents for PCI in people with Ischaemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Coronary Drug Eluting Stents for PCI
- Type of treatment
- Medical device
- How many people
- 322 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2002to Jun 2006
- Phase
- Interventional
- 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
- Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter > 2.25 mm.
- Complex lesions to be included should have at least one of the following characteristics:
- Ostial in location (< 5 mm from ostium)
- Total occlusions with a length ≥ 15 mm
- Bifurcational (side branch > 1.75 mm in diameter)
- Angulated (> 45° within lesion)
Who cannot join
- Patients:
- Other severe disease with an expected survival < 1 year
- Other significant cardiac disease
- Known allergy against paclitaxel, clopidogrel or stainless steel.
- Myocardial infarction within 3 days of the index procedure
- Linguistic difficulties needing an interpreter
Show all 18Show fewer
- Renal insufficiency (p-creatinine > 200 micromol/l)
- Gastrointestinal bleeding within 1 month
- Childbearing potential or pregnancy
- Participation in another study
- Lesions:
- Unprotected left main disease
- Restenosis
- Lesions containing visible thrombus
- Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
- Diffuse coronary disease distal to the treated lesion
- Heavily calcification
- Lesion located in saphenous vein graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.
- Conditions
- Ischaemic Heart Disease
- Being tested
- Coronary Drug Eluting Stents for PCI
- Keywords
- Coronary complex lesions, Restenosis, Drug eluting stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Drug Eluting Stents for PCIDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal lumen diameter
Frequency of restenosis (>50%) at 6 months.
Secondary outcomes (1)
Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2002
- Study completionJun 2006
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 Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henning Kelbaek, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151658
- Sponsor's protocol ID
- SCANDSTENT
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Publications
Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6. doi: 10.1016/j.jacc.2008.01.056.
PubMed 18498953
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent
- ClinicalTrials.gov ID
- NCT00151658
- Acronym / sponsor ID
- SCANDSTENT
- Conditions
- Ischaemic Heart Disease
- Keywords
- Coronary complex lesions, Restenosis, Drug eluting stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Jun 2006
- First posted
- 9 Sep 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.
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter > 2.25 mm.
- Ostial in location (< 5 mm from ostium)
- Total occlusions with a length ≥ 15 mm
- Bifurcational (side branch > 1.75 mm in diameter)
- Angulated (> 45° within lesion)
Key exclusion criteria (18 listed)
- Other severe disease with an expected survival < 1 year
- Other significant cardiac disease
- Known allergy against paclitaxel, clopidogrel or stainless steel.
- Myocardial infarction within 3 days of the index procedure
- Linguistic difficulties needing an interpreter
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 |
|---|---|---|
| Coronary Drug Eluting Stents for PCI | Device | – |
Primary outcome
Minimal lumen diameter
Frequency of restenosis (>50%) at 6 months.
1 secondary outcome
Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 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 14 Sep 2005.
- Derived from this study: PubMed 18498953Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6. doi: 10.1016/j.jacc.2008.01.056.
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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.
Henning Kelbaek, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Drug Eluting Stents for PCI in people with Ischaemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 inclusion and 18 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 Sep 2005. 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 Denmark. 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.
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?
Minimal lumen diameter. The study lists 2 primary outcomes in all. 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 NCT00151658, 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 14 Sep 2005.