Coronary Artery BypassPhase 4SOS-Xience VNCT00911976
Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions
A Phase 4 study testing Xience V coronary stent in people with Coronary Artery Bypass and Atherosclerosis, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary saphenous vein bypass graft lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass, Atherosclerosis
- What is being tested?
- Xience V coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2011
- Phase
- Phase 4
- 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
- Age > 18 years
- Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.5 and 4.5 mm in diameter, is ≤ 22 mm in length, and can be treated with implantation of a single stent
- Use of an embolic protection device during the SVG intervention
- Able and willing to return for angiographic follow-up after 12 months
- Agree to participate and provide informed consent
Who cannot join
- Use of stents other than the Xience V stent
- Planned non-cardiac surgery within the following 12 months
- Presentation with an ST-segment elevation acute myocardial infarction
- Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
- Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
- Hemorrhagic diatheses, or refusal to receive blood transfusions
Show all 13Show fewer
- Current treatment with warfarin
- Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
- Coexisting conditions that limit life expectancy to less than 12 months
- Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
- Patients allergic to contrast material that can not be adequately premedicated
- History of an allergic reaction or significant sensitivity to everolimus
- Documented left ventricular ejection fraction (LVEF) < 25% at most recent evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Healthcare System
Dallas, Texas, 75216
About this study
Official title: Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Stenting Of Saphenous Vein Grafts Xience V Angiographic Study (SOS-Xience V)
The specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary saphenous vein bypass graft lesions.
Read the detailed description
Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-stent restenosis. Although drug-eluting stents (DES) appear promising, there are limited and conflicting data on their efficacy and safety in SVGs. Our group recently completed and reported the results of the SOS (Stenting Of Saphenous vein grafts) trial that compared a paclitaxel-eluting stent with a similar BMS. There is currently no data on the use of the second generation DES in these challenging lesions. The SOS-Xience V study will examine the effects of the Xience V everolimus-eluting stent in SVG lesions.
The specific aim of SOS-Xience V is to examine the 12-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the target segment) after implantation of the Xience V stent in SVG lesions.
The Xience V stent will be implanted in 40 consecutive patients who need stenting of a SVG lesion. Patients will undergo repeat follow-up angiography and intravascular ultrasonography at 12 months and will be followed clinically for 12 months to determine:
- the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography (primary study endpoint), and
- intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography, and (b) 12-month incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) (secondary study endpoints), and (c) percent stent strut coverage by optical coherence tomography
- Conditions
- Coronary Artery Bypass, Atherosclerosis
- Being tested
- Xience V coronary stent
- Keywords
- Coronary artery bypass, Stents, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis, Everolimus, Saphenous vein grafts
- Medical subject headings
- Atherosclerosis, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xience V coronary stentDevice
The Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions
| Study group | Role | What they receive |
|---|---|---|
| Xience V | Experimental | Implantation of the Xience V stent in saphenous vein graft lesions Receives: Device: Xience V coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography
Measured: 12 months
Secondary outcomes (3)
intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography
Measured: 12 months
incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization)
Measured: 12 months
Percent stent strut coverage by optical coherence tomography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
- Investigators
- Emmanouil S Brilakis, MD, PhD, Principal investigator, North Texas Veterans Healthcare SystemSubhash Banerjee, MD, Study director, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911976
- Sponsor's protocol ID
- 09-016
- Acronym
- SOS-Xience V
- Status last verified
- Oct 2012
- First submitted
- 2 Jun 2009
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Papayannis AC, Michael TT, Yangirova D, Abdel-Karim AR, Kohlhaas J, Mahmood A, Addo T, Haagen D, Makke L, Roesle M, Rangan B, Banerjee S, Brilakis ES. Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions. J Invasive Cardiol. 2012 Aug;24(8):390-4.
PubMed 22865309
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Stenting Of Saphenous Vein Grafts Xience V Angiographic Study (SOS-Xience V)
- ClinicalTrials.gov ID
- NCT00911976
- Acronym / sponsor ID
- SOS-Xience V / 09-016
- Conditions
- Coronary Artery Bypass, Atherosclerosis
- Keywords
- Coronary artery bypass, Stents, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis, Everolimus, Saphenous vein grafts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Jun 2009 (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 specific aim of the SOS-Xience V study is to examine the 12-month incidence of binary angiographic in-stent restenosis after implantation of the Xience V stent in aortocoronary saphenous vein bypass graft lesions.
Detailed description
Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-stent restenosis. Although drug-eluting stents (DES) appear promising, there are limited and conflicting data on their efficacy and safety in SVGs. Our group recently completed and reported the results of the SOS (Stenting Of Saphenous vein grafts) trial that compared a paclitaxel-eluting stent with a similar BMS. There is currently no data on the use of the second generation DES in these challenging lesions. The SOS-Xience V study will examine the effects of the Xience V everolimus-eluting stent in SVG lesions.
The specific aim of SOS-Xience V is to examine the 12-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of > 50% of the minimum lumen diameter of the target segment) after implantation of the Xience V stent in SVG lesions.
The Xience V stent will be implanted in 40 consecutive patients who need stenting of a SVG lesion. Patients will undergo repeat follow-up angiography and intravascular ultrasonography at 12 months and will be followed clinically for 12 months to determine:
- the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography (primary study endpoint), and
- intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography, and (b) 12-month incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) (secondary study endpoints), and (c) percent stent strut coverage by optical coherence tomography
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xience V | Experimental | Device: Xience V coronary stentImplantation of the Xience V stent in saphenous vein graft lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.5 and 4.5 mm in diameter, is ≤ 22 mm in length, and can be treated with implantation of a single stent
- Use of an embolic protection device during the SVG intervention
- Able and willing to return for angiographic follow-up after 12 months
- Agree to participate and provide informed consent
Key exclusion criteria (13 listed)
- Use of stents other than the Xience V stent
- Planned non-cardiac surgery within the following 12 months
- Presentation with an ST-segment elevation acute myocardial infarction
- Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
- Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
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 |
|---|---|---|
| Xience V coronary stentThe Xience V stent will be implanted in aortocoronary saphenous vein bypass graft lesions | Device | Xience V |
Primary outcome
the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography
Time frame: 12 months
3 secondary outcomes
intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography
Time frame: 12 months
incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization)
Time frame: 12 months
Percent stent strut coverage by optical coherence tomography
Time frame: 12 months
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 Oct 2012.
- Results publication: PubMed 22865309Papayannis AC, Michael TT, Yangirova D, Abdel-Karim AR, Kohlhaas J, Mahmood A, Addo T, Haagen D, Makke L, Roesle M, Rangan B, Banerjee S, Brilakis ES. Optical coherence tomography analysis of the stenting of saphenous vein graft (SOS) Xience V Study: use of the everolimus-eluting stent in saphenous vein graft lesions. J Invasive Cardiol. 2012 Aug;24(8):390-4.
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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
North Texas Veterans Healthcare System
Subhash Banerjee, MD study director
North Texas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xience V coronary stent in people with Coronary Artery Bypass and Atherosclerosis, run by North Texas Veterans Healthcare System at 1 site in United States.
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 5 inclusion and 13 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 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the incidence of 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 NCT00911976, which also lists 1 linked publication.
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 Oct 2012.