AngioplastyNCT00738556
Spot Drug-Eluting Stenting for Long Coronary Stenoses
A study testing Drug-eluting stents (Cypher and Taxus) in people with Angioplasty, run by Cardiovascular Research Society, Greece at 2 sites in Greece.
Trial summary
Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Angioplasty
- What is being tested?
- Drug-eluting stents (Cypher and Taxus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2003to Sep 2007
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.
Who cannot join
- Unprotected left main coronary artery stenosis,
- Left ventricular ejection fraction <25%, OR
- Contraindication to aspirin or clopidogrel
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study
Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.
Read the detailed description
Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (>20 mm) lesions and indications for percutaneous coronary intervention.
- Conditions
- Angioplasty
- Being tested
- Drug-eluting stents (Cypher and Taxus)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting stents (Cypher and Taxus)Device
Also called Sirolimus-eluting stents (Cypher, J&J), Paclitaxel-eluting stents (Taxus, Boston Scientific)
Spot or full length stenting of a coronary lesion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Full cover stenting of coronary lesions Receives: Device: Drug-eluting stents (Cypher and Taxus) |
| 2 | Active comparator | Spot-stenting of significantly stenotic parts of a coronary lesion Receives: Device: Drug-eluting stents (Cypher and Taxus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJan 2003
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AngioplastyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Society, Greece
- Sponsor type
- University, hospital or other
- Investigators
- Demosthenes Katritsis, MD, PhD, Study chair, Athens Euroclinic and Cardiovasdcular Research Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738556
- Sponsor's protocol ID
- 2.15.8.08
- Status last verified
- Jan 2009
- First submitted
- 18 Aug 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katritsis DG, Korovesis S, Karabinos I, Giazitzoglou E, Theodorou S, Karvouni E, Voridis E. Sirolimus-versus paclitaxel-eluting stents: a comparison of two consecutive series in routine clinical practice. J Interv Cardiol. 2006 Feb;19(1):31-7. doi: 10.1111/j.1540-8183.2006.00101.x.
PubMed 16483337Katritsis DG, Korovesis S, Karvouni E, Giazitzoglou E, Theodorou S, Kourlaba G, Panagiotakos D, Voridis E. Direct versus predilatation drug-eluting stenting: a randomized clinical trial. J Invasive Cardiol. 2006 Oct;18(10):475-9.
PubMed 17235419Karvouni E, Korovesis S, Katritsis DG. Very late thrombosis after implantation of sirolimus eluting stent. Heart. 2005 Jun;91(6):e45. doi: 10.1136/hrt.2004.056341.
PubMed 15894746Katritsis DG, Karvouni E, Ioannidis JP. Meta-analysis comparing drug-eluting stents with bare metal stents. Am J Cardiol. 2005 Mar 1;95(5):640-3. doi: 10.1016/j.amjcard.2004.10.041.
PubMed 15721109
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT00738556
- Acronym / sponsor ID
- 2.15.8.08
- Conditions
- Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Cardiovascular Research Society, GreeceUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Aug 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.
Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.
Detailed description
Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (>20 mm) lesions and indications for percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Drug-eluting stents (Cypher and Taxus)Full cover stenting of coronary lesions |
| 2 | Active comparator | Device: Drug-eluting stents (Cypher and Taxus)Spot-stenting of significantly stenotic parts of a coronary lesion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.
Key exclusion criteria (3 listed)
- Unprotected left main coronary artery stenosis,
- Left ventricular ejection fraction <25%, OR
- Contraindication to aspirin or clopidogrel
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 |
|---|---|---|
| Drug-eluting stents (Cypher and Taxus)Also: Sirolimus-eluting stents (Cypher, J&J), Paclitaxel-eluting stents (Taxus, Boston Scientific)Spot or full length stenting of a coronary lesion | Device | 1, 2 |
Primary outcome
Major adverse cardiac events
Time frame: 3 years
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 29 Jan 2009.
- Background: PubMed 16483337Katritsis DG, Korovesis S, Karabinos I, Giazitzoglou E, Theodorou S, Karvouni E, Voridis E. Sirolimus-versus paclitaxel-eluting stents: a comparison of two consecutive series in routine clinical practice. J Interv Cardiol. 2006 Feb;19(1):31-7. doi: 10.1111/j.1540-8183.2006.00101.x.
- Background: PubMed 17235419Katritsis DG, Korovesis S, Karvouni E, Giazitzoglou E, Theodorou S, Kourlaba G, Panagiotakos D, Voridis E. Direct versus predilatation drug-eluting stenting: a randomized clinical trial. J Invasive Cardiol. 2006 Oct;18(10):475-9.
- Background: PubMed 15894746Karvouni E, Korovesis S, Katritsis DG. Very late thrombosis after implantation of sirolimus eluting stent. Heart. 2005 Jun;91(6):e45. doi: 10.1136/hrt.2004.056341.
- Background: PubMed 15721109Katritsis DG, Karvouni E, Ioannidis JP. Meta-analysis comparing drug-eluting stents with bare metal stents. Am J Cardiol. 2005 Mar 1;95(5):640-3. doi: 10.1016/j.amjcard.2004.10.041.
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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.
Demosthenes Katritsis, MD, PhD study chair
Athens Euroclinic and Cardiovasdcular Research Society
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting stents (Cypher and Taxus) in people with Angioplasty, run by Cardiovascular Research Society, Greece at 2 sites in Greece.
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 1 inclusion and 3 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 29 Jan 2009. 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 Greece. 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?
Major adverse cardiac events (time frame: 3 years). 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 NCT00738556, which also lists 4 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 29 Jan 2009.