Spot Drug-Eluting Stenting for Long Coronary Stenoses
Primary Purpose
Angioplasty
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Drug-eluting stents (Cypher and Taxus)
Sponsored by
About this trial
This is an interventional treatment trial for Angioplasty
Eligibility Criteria
Inclusion Criteria:
- Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.
Exclusion Criteria:
- Unprotected left main coronary artery stenosis,
- Left ventricular ejection fraction <25%, OR
- Contraindication to aspirin or clopidogrel
Sites / Locations
- Athens Euroclinic
- Athens Euroclinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Full cover stenting of coronary lesions
Spot-stenting of significantly stenotic parts of a coronary lesion
Outcomes
Primary Outcome Measures
Major adverse cardiac events
Secondary Outcome Measures
Full Information
NCT ID
NCT00738556
First Posted
August 18, 2008
Last Updated
January 28, 2009
Sponsor
Cardiovascular Research Society, Greece
1. Study Identification
Unique Protocol Identification Number
NCT00738556
Brief Title
Spot Drug-Eluting Stenting for Long Coronary Stenoses
Official Title
Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cardiovascular Research Society, Greece
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Full cover stenting of coronary lesions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Spot-stenting of significantly stenotic parts of a coronary lesion
Intervention Type
Device
Intervention Name(s)
Drug-eluting stents (Cypher and Taxus)
Other Intervention Name(s)
Sirolimus-eluting stents (Cypher, J&J), Paclitaxel-eluting stents (Taxus, Boston Scientific)
Intervention Description
Spot or full length stenting of a coronary lesion
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.
Exclusion Criteria:
Unprotected left main coronary artery stenosis,
Left ventricular ejection fraction <25%, OR
Contraindication to aspirin or clopidogrel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demosthenes Katritsis, MD, PhD
Organizational Affiliation
Athens Euroclinic and Cardiovasdcular Research Society
Official's Role
Study Chair
Facility Information:
Facility Name
Athens Euroclinic
City
Athens
State/Province
Attica
ZIP/Postal Code
11521
Country
Greece
Facility Name
Athens Euroclinic
City
Athens
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
16483337
Citation
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.
Results Reference
background
PubMed Identifier
17235419
Citation
Katritsis 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.
Results Reference
background
PubMed Identifier
15894746
Citation
Karvouni 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.
Results Reference
background
PubMed Identifier
15721109
Citation
Katritsis 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.
Results Reference
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Spot Drug-Eluting Stenting for Long Coronary Stenoses
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