NCT00693030

Brief Summary

Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

Enrollment Period

1.8 years

First QC Date

June 4, 2008

Last Update Submit

June 5, 2008

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseasePercutaneous Coronary InterventionsDrug-Eluting stentsOptical Coherence TomographyThrombosisLong lesions in native vessel requiring stents in overlap

Outcome Measures

Primary Outcomes (1)

  • Number of uncovered and/or malapposed stent struts at overlapping versus non overlapping sites in drug eluting vs bare metal stents

    6 months

Secondary Outcomes (2)

  • Ischemia Driven Target Vessel Failure

    12 months

  • Number of uncovered and/or malapposed stent struts at overlapping sites in sirolimus-, paclitaxel- or zotarolimus eluting stents

    6 months

Study Arms (4)

1

ACTIVE COMPARATOR

Device, Sirolimus drug-eluting stents implanted in overlap

Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)

2

ACTIVE COMPARATOR

Device, paclitaxel polymer drug eluting stent

Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)

3

ACTIVE COMPARATOR

Device, zotarolimus drug eluting stent

Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)

4

ACTIVE COMPARATOR

bare metal coronary stents

Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)

Interventions

sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)DEVICE

comparison of multiple drug eluting stents

Also known as: Cypher™ (Cordis Corp, Johnson & Johnson Co) DES
1
paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)DEVICE

comparison of multiple drug eluting coronary stents

Also known as: Taxus Libertè™ (Boston Scientific, Natick MS) DES
2
zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)DEVICE

comparison of multiple drug eluting coronary stents

Also known as: Endeavor™ (Medtronic, Santa Rosa, CA) DES
3
Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)DEVICE

comparison of DES in overlap vs BMS in overlap

Also known as: Libertè™ BMS(Boston Scientific, Natick, MS)
4

Eligibility Criteria

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

You may qualify if:

  • Native coronary artery disease with ≥ 75% diameter stenosis
  • Lesion length ≥ 20 mm,
  • Vessel size in between 2.5 and 3.5 mm.
  • Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
  • Signed patient informed consent

You may not qualify if:

  • left main coronary artery disease,
  • lesions in coronary artery bypass grafts,
  • acute myocardial infarction,
  • poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
  • allergy to aspirin and or clopidogrel/ticlo,
  • renal failure with creatinine value \> 2.5,
  • no suitable anatomy for OCT scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

RECRUITING

Related Publications (10)

  • Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

    PMID: 16814667BACKGROUND

  • Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorija K, Weber DK, Gold HK, Virmani R. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005 Jul 12;112(2):270-8. doi: 10.1161/CIRCULATIONAHA.104.508937. Epub 2005 Jul 5.

    PMID: 15998681BACKGROUND

  • Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

    PMID: 17438147BACKGROUND

  • Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007 Jul;27(7):1500-10. doi: 10.1161/ATVBAHA.107.144220. Epub 2007 May 17.

    PMID: 17510464BACKGROUND

  • Nakazawa G, Finn AV, John MC, Kolodgie FD, Virmani R. The significance of preclinical evaluation of sirolimus-, paclitaxel-, and zotarolimus-eluting stents. Am J Cardiol. 2007 Oct 22;100(8B):36M-44M. doi: 10.1016/j.amjcard.2007.08.020.

    PMID: 17950831BACKGROUND

  • Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

    PMID: 17135281BACKGROUND

  • Bouma BE, Tearney GJ, Yabushita H, Shishkov M, Kauffman CR, DeJoseph Gauthier D, MacNeill BD, Houser SL, Aretz HT, Halpern EF, Jang IK. Evaluation of intracoronary stenting by intravascular optical coherence tomography. Heart. 2003 Mar;89(3):317-20. doi: 10.1136/heart.89.3.317.

    PMID: 12591841BACKGROUND

  • Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, Ohba T, Mizuno K. Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 2007 Apr 15;99(8):1033-8. doi: 10.1016/j.amjcard.2006.11.068. Epub 2007 Feb 23.

    PMID: 17437723BACKGROUND

  • Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.

    PMID: 18307999BACKGROUND

  • Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA; ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.

    PMID: 20488410DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseThrombosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesEmbolism and Thrombosis

Study Officials

  • Giulio Guagliumi, MD

    Cardiovascular Department Ospedali Riuniti di Bergamo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monia Lorini, MD

CONTACT

39-03-526-9751mlorini@ospedaliriuniti.bergamo.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

August 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

June 6, 2008

Record last verified: 2008-06

Locations

IT(1)