NCT00738556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

4.7 years

First QC Date

August 18, 2008

Last Update Submit

January 28, 2009

Conditions

Angioplasty

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    3 years

Study Arms (2)

1

ACTIVE COMPARATOR

Full cover stenting of coronary lesions

Device: Drug-eluting stents (Cypher and Taxus)

2

ACTIVE COMPARATOR

Spot-stenting of significantly stenotic parts of a coronary lesion

Device: Drug-eluting stents (Cypher and Taxus)

Interventions

Drug-eluting stents (Cypher and Taxus)DEVICE

Spot or full length stenting of a coronary lesion

Also known as: Sirolimus-eluting stents (Cypher, J&J), Paclitaxel-eluting stents (Taxus, Boston Scientific)
12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.

You may not qualify if:

  • Unprotected left main coronary artery stenosis,
  • Left ventricular ejection fraction \<25%, OR
  • Contraindication to aspirin or clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Athens Euroclinic

Athens, Attica, 11521, Greece

Location

Athens Euroclinic

Athens, Greece

Location

Related Publications (4)

  • 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.

    PMID: 16483337BACKGROUND

  • 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.

    PMID: 17235419BACKGROUND

  • 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.

    PMID: 15894746BACKGROUND

  • 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.

    PMID: 15721109BACKGROUND

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Demosthenes Katritsis, MD, PhD

    Athens Euroclinic and Cardiovasdcular Research Society

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

January 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

GR(2)