Coronary Artery BypassPhase 3NCT00247208
The SOS (Stenting Of Saphenous Vein Grafts) Trial
A Phase 3 study testing Taxus polymer-based paclitaxel-eluting stent and Express 2 bare metal stent in people with Coronary Artery Bypass and Arteriosclerosis, run by North Texas Veterans Healthcare System at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass, Arteriosclerosis
- What is being tested?
- Taxus polymer-based paclitaxel-eluting stent and Express 2 bare metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2005to Jun 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
VA North Texas Health Care System
Dallas, Texas, 75216
Michael E. Debakey VA Medical Center
Houston, Texas, 77030
VA Iowa City Healthcare system
Iowa City, Iowa, 52246
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: The SOS (Stenting Of Saphenous Vein Grafts) Randomized-controlled Trial of a Paclitaxel-eluting Stent vs. a Bare Metal Stent in Saphenous Vein Graft Lesions
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.
Read the detailed description
Introduction: The prevalence of coronary artery bypass graft (CABG) surgery is high in the veteran population. Saphenous veins are used as conduits in the majority of CABG operations. Compared to arterial conduits, saphenous vein grafts (SVGs) have a high rate of failure, requiring percutaneous coronary intervention (PCI) or repeat CABG. Bare metal stents are currently used in the majority of PCI in SVGs because they increase the procedural success rate and decrease restenosis. However, even with the use of bare metal stents, restenosis still occurs in 37-53% of the SVGs, often requiring repeat target vein graft revascularization.
Drug-eluting stents (DES) have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries. Even though, no randomized controlled trials have compared DES with bare stents in SVG interventions, DES are increasingly being used off label in this setting, based on registry data. DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries. We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent (which is identical to the paclitaxel-eluting stent but has no drug coating) in saphenous vein graft lesions.
Hypothesis: Compared to implantation of a bare metal stent, implantation of a similar paclitaxel-eluting stent (Taxus™, Boston Scientific, Nattick, Massachusetts) in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months.
Specific objectives: We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent (Taxus™) in order to determine:
- whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography (primary study endpoint), and
- whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization, target vessel failure, overall major adverse cardiac and cerebrovascular events, and intra-stent intimal hyperplasia accumulation, as measured by intravascular ultrasound (secondary endpoints).
- Conditions
- Coronary Artery Bypass, Arteriosclerosis
- Being tested
- Taxus polymer-based paclitaxel-eluting stent, Express 2 bare metal stent
- Keywords
- Coronary artery bypass, Stents, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis, Paclitaxel
- Medical subject headings
- Arteriosclerosis, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxus polymer-based paclitaxel-eluting stentDevice
Also called Taxus drug-eluting stents
Two different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Express 2 bare metal stent Receives: Device: Express 2 bare metal stent |
| 2 | Experimental | Taxus, paclitaxel-eluting stent Receives: Device: Taxus polymer-based paclitaxel-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography
Measured: 12 months
Secondary outcomes (2)
intrastent intimal hyperplasia accumulation as measured by IVUS
Measured: 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
Measured: 12 months for IVUS and 24 months for clinical follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startMay 2005
- Primary completionOct 2008
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Clark R. Gregg Fund, Harris Methodist Foundation, University of Arkansas, US Department of Veterans Affairs, Michael E. DeBakey VA Medical Center, Southern Arizona VA Health Care System, Onassis Cardiac Surgery Centre
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
- Investigators
- Emmanouil S Brilakis, MD, PhD, Principal investigator, VA North Texas Health Care System, University of Texas Southwestern Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247208
- Sponsor's protocol ID
- VISN 17, 10N17
- Status last verified
- Apr 2012
- First submitted
- 31 Oct 2005
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19281920Lichtenwalter 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.
PubMed 19778774Michael 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.
PubMed 21646644Brilakis 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.
PubMed 21349456Michael 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.
PubMed 21200334Badhey 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.
PubMed 20665875
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SOS (Stenting Of Saphenous Vein Grafts) Randomized-controlled Trial of a Paclitaxel-eluting Stent vs. a Bare Metal Stent in Saphenous Vein Graft Lesions
- ClinicalTrials.gov ID
- NCT00247208
- Acronym / sponsor ID
- VISN 17, 10N17
- Conditions
- Coronary Artery Bypass, Arteriosclerosis
- Keywords
- Coronary artery bypass, Stents, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis, Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Collaborators
- Clark R. Gregg Fund, Harris Methodist Foundation, University of Arkansas, US Department of Veterans Affairs, Michael E. DeBakey VA Medical Center, Southern Arizona VA Health Care System, Onassis Cardiac Surgery Centre
- Study start
- May 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Nov 2005 (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.
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.
Detailed description
Introduction: The prevalence of coronary artery bypass graft (CABG) surgery is high in the veteran population. Saphenous veins are used as conduits in the majority of CABG operations. Compared to arterial conduits, saphenous vein grafts (SVGs) have a high rate of failure, requiring percutaneous coronary intervention (PCI) or repeat CABG. Bare metal stents are currently used in the majority of PCI in SVGs because they increase the procedural success rate and decrease restenosis. However, even with the use of bare metal stents, restenosis still occurs in 37-53% of the SVGs, often requiring repeat target vein graft revascularization.
Drug-eluting stents (DES) have been a major breakthrough in percutaneous coronary intervention because they significantly reduce the incidence of in-stent restenosis in de novo lesions of native coronary arteries. Even though, no randomized controlled trials have compared DES with bare stents in SVG interventions, DES are increasingly being used off label in this setting, based on registry data. DES are expensive and may not provide benefit in SVGs since the atherosclerotic process is different in SVGs and in native coronary arteries. We propose to compare the 12-month angiographic restenosis rates after implantation of a polymer-based paclitaxel-eluting stent or the Express-2 bare metal stent (which is identical to the paclitaxel-eluting stent but has no drug coating) in saphenous vein graft lesions.
Hypothesis: Compared to implantation of a bare metal stent, implantation of a similar paclitaxel-eluting stent (Taxus™, Boston Scientific, Nattick, Massachusetts) in saphenous vein graft lesion will reduce the incidence of angiographic in-stent restenosis after 12 months.
Specific objectives: We propose to randomize patients undergoing stenting of a saphenous vein graft lesion to a bare metal stent or an identical paclitaxel-eluting stent (Taxus™) in order to determine:
- whether the paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography (primary study endpoint), and
- whether the paclitaxel-eluting stent will reduce the 24-month incidence of ischemia-driven target vessel revascularization, target vessel failure, overall major adverse cardiac and cerebrovascular events, and intra-stent intimal hyperplasia accumulation, as measured by intravascular ultrasound (secondary endpoints).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Express 2 bare metal stentExpress 2 bare metal stent |
| 2 | Experimental | Device: Taxus polymer-based paclitaxel-eluting stentTaxus, paclitaxel-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Taxus polymer-based paclitaxel-eluting stentAlso: Taxus drug-eluting stentsTwo different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions. | Device | 2 |
| Express 2 bare metal stentTwo different types of stents (paclitaxel-eluting and a similar bare metal stent) are being compared in saphenous vein graft lesions. | Device | 1 |
Primary outcome
binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography
Time frame: 12 months
2 secondary outcomes
intrastent intimal hyperplasia accumulation as measured by IVUS
Time frame: 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
Time frame: 12 months for IVUS and 24 months for clinical follow-up
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 26 Apr 2012.
- Results publication: PubMed 19281920Brilakis 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.
- Results publication: PubMed 19778774Lichtenwalter 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.
- Results publication: PubMed 21646644Michael 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.
- Results publication: PubMed 21349456Brilakis 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.
- Results publication: PubMed 21200334Michael 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.
- Results publication: PubMed 20665875Badhey 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.
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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.
Emmanouil S Brilakis, MD, PhD principal investigator
VA North Texas Health Care System, University of Texas Southwestern Medical School
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taxus polymer-based paclitaxel-eluting stent and Express 2 bare metal stent in people with Coronary Artery Bypass and Arteriosclerosis, run by North Texas Veterans Healthcare System at 5 sites in 2 countries.
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 3 inclusion and 10 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 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography (time frame: 12 months). 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 NCT00247208, which also lists 6 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 26 Apr 2012.