Coronary Artery DiseaseNCT00192881
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
A study testing Bx Sonic & Cypher stent from Cordis in people with Coronary Artery 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
- Coronary Artery Disease
- What is being tested?
- Bx Sonic & Cypher stent from Cordis
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Oct 2002to not given
- 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
- Informed consent
- Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty
- 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)
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- 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 ticlopidine),
- Myocardial infarction within 3 days of the index procedure
- Linguistic difficulties needing an interpreter
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- 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.
Henning Kelbaek, MD contact
Lene Kloevgaard, RN contact
Denmark1 site
Rigshospitalet, Cardiac Cath Lab
Copenhagen, DK-2100
Henning Kelbaek, MD, henning.kelbaek@rh.hosp.dk
About this study
Official title: Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions
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
- Coronary Artery Disease
- Being tested
- Bx Sonic & Cypher stent from Cordis
- Keywords
- Percutaneous coronary intervention, Balloon angioplasty, Restenosis, 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.
Bx Sonic & Cypher stent from CordisDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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)
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
- NCT00192881
- Sponsor's protocol ID
- SCANDSTENT A
- Status last verified
- Jul 2010
- First submitted
- 12 Sep 2005
- Last updated
- 18 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions
- ClinicalTrials.gov ID
- NCT00192881
- Acronym / sponsor ID
- SCANDSTENT A
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Balloon angioplasty, Restenosis, Stents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2002
- First posted
- 19 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 (9 listed)
- Stable, or unstable angina and/or objective signs of myocardial ischaemia
- Informed consent
- Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty
- 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:
Key exclusion criteria (18 listed)
- Other severe disease with an expected survival < 1 year
- Other significant cardiac disease
- Known allergy against paclitaxel, clopidogrel (or ticlopidine),
- 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 |
|---|---|---|
| Bx Sonic & Cypher stent from Cordis | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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 contact
Lene Kloevgaard, RN contact
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 Bx Sonic & Cypher stent from Cordis in people with Coronary Artery 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 9 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: status not confirmed, as of the sponsor's last update on 18 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henning Kelbaek, MD (henning.kelbaek@rh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 18 Aug 2010.