NCT00247208

Brief Summary

The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Longer than P75 for phase_3

Geographic Reach
2 countries

5 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

May 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

3.4 years

First QC Date

October 31, 2005

Last Update Submit

April 25, 2012

Conditions

Coronary Artery BypassArteriosclerosis

Keywords

Coronary artery bypassStentsAngioplasty, Transluminal, Percutaneous CoronaryCoronary RestenosisPaclitaxel

Outcome Measures

Primary Outcomes (1)

  • binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography

    12 months

Secondary Outcomes (2)

  • intrastent intimal hyperplasia accumulation as measured by IVUS

    12 months for IVUS and 24 months for clinical follow-up

  • incidence of ischemia-driven target vessel revascularization, target vessel failure, and overall major adverse cardiac and cerebrovascular events at 24-month follow-up

    12 months for IVUS and 24 months for clinical follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

Express 2 bare metal stent

Device: Express 2 bare metal stent

2

EXPERIMENTAL

Taxus, paclitaxel-eluting stent

Device: Taxus polymer-based paclitaxel-eluting stent

Interventions

Taxus polymer-based paclitaxel-eluting stentDEVICE

Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.

Also known as: Taxus drug-eluting stents
2
Express 2 bare metal stentDEVICE

Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.

1

Eligibility Criteria

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

You may qualify if:

  • at least one 50-99% de-novo or restenotic lesion in a saphenous vein graft that is between 2.5 and 4.0 mm in diameter, requiring percutaneous coronary intervention according to the opinion of the attending cardiologist
  • willing to return for repeat coronary angiography after 12 months
  • able to give informed consent

You may not qualify if:

  • previous or planned use of intravascular brachytherapy in the target vessel
  • a left ventricular ejection fraction of less than 25 percent
  • hemorrhagic diatheses
  • contraindications or allergy to aspirin, thienopyridines, paclitaxel, or stainless steel
  • a history of anaphylaxis in response to iodinated contrast medium
  • use of paclitaxel within 12 months before study entry or current use of colchicine
  • a serum creatinine level of more than 2.0 mg per deciliter (177 µmol per liter)
  • a leukocyte count of less than 3500 per cubic millimeter, or a platelet count of less than 100,000 per cubic millimeter
  • a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy
  • coexisting conditions that limit life expectancy to less than 24 months or that could affect a patient's compliance with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

VA Iowa City Healthcare system

Iowa City, Iowa, 52246, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Michael E. Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

Onassis Cardiac Surgery Center

Athens, 17674, Greece

Location

Related Publications (6)

  • Brilakis ES, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Haagen D, Saeed B, Gadiparthi C, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S. A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial. J Am Coll Cardiol. 2009 Mar 17;53(11):919-28. doi: 10.1016/j.jacc.2008.11.029.

    PMID: 19281920RESULT

  • Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Holper EM, Haagen D, Saeed B, Iturbe JM, Shunk K, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S, Brilakis ES. Clinical presentation and angiographic characteristics of saphenous vein graft failure after stenting: insights from the SOS (stenting of saphenous vein grafts) trial. JACC Cardiovasc Interv. 2009 Sep;2(9):855-60. doi: 10.1016/j.jcin.2009.06.014.

    PMID: 19778774RESULT

  • Michael TT, Abdel-karim AR, Papayannis A, Lichtenwalter C, de Lemos JA, Obel O, Addo T, Roesle M, Haagen D, Rangan BV, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger PB, Banerjee S, Brilakis ES. Recurrent cardiovascular events with paclitaxel-eluting versus bare-metal stents in saphenous vein graft lesions: insights from the SOS (Stenting of Saphenous Vein Grafts) trial. J Invasive Cardiol. 2011 Jun;23(6):216-9.

    PMID: 21646644RESULT

  • Brilakis ES, Lichtenwalter C, Abdel-karim AR, de Lemos JA, Obel O, Addo T, Roesle M, Haagen D, Rangan BV, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S. Continued benefit from paclitaxel-eluting compared with bare-metal stent implantation in saphenous vein graft lesions during long-term follow-up of the SOS (Stenting of Saphenous Vein Grafts) trial. JACC Cardiovasc Interv. 2011 Feb;4(2):176-82. doi: 10.1016/j.jcin.2010.10.003.

    PMID: 21349456RESULT

  • Michael TT, Badhey N, Banerjee S, Brilakis ES. Comparison of characteristics and outcomes of patients undergoing saphenous vein graft stenting who were or were not enrolled in the stenting of saphenous vein grafts randomized controlled trial. J Investig Med. 2011 Feb;59(2):259-66. doi: 10.231/JIM.0b013e318207066c.

    PMID: 21200334RESULT

  • Badhey N, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Addo TA, Haagen D, Abdel-Karim AR, Saeed B, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger PB, Banerjee S, Brilakis ES. Contemporary use of embolic protection devices in saphenous vein graft interventions: Insights from the stenting of saphenous vein grafts trial. Catheter Cardiovasc Interv. 2010 Aug 1;76(2):263-9. doi: 10.1002/ccd.22438.

    PMID: 20665875RESULT

Related Links

MeSH Terms

Conditions

ArteriosclerosisCoronary Restenosis

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary StenosisCoronary DiseaseMyocardial IschemiaHeart Diseases

Study Officials

  • Emmanouil S Brilakis, MD, PhD

    VA North Texas Health Care System, University of Texas Southwestern Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Catheterization Laboratories, VA North Texas Healthcare System

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2008

Study Completion

June 1, 2011

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

US(4)GR(1)