Coronary Artery Bypass GraftingPhase 4VELETINCT00289835
Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial
A Phase 4 study testing Paclitaxel eluting stent in people with Coronary Artery Bypass Grafting, run by Laval University at 1 site in Canada.
Trial summary
HYPOTHESIS 1. Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS. 2. Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS. OBJECTIVES 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- Paclitaxel eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2006to Oct 2008
- 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
- Written and signed informed consent.
- Patients ≥18 years old.
- Clinical indication for cardiac catheterization and SVG angiography.
- Presence of at least one SVG lesion of 30% to 70% diameter stenosis by visual estimation which is (are) not the culprit lesion (s) responsible for the clinical syndrome of the patient.
Who cannot join
- Ejection fraction <20%.
- Renal insufficiency with creatinine > 250 mg/dl.
- Presence of more than 3 moderate SVG stenosis or significant diffuse SVG disease.
- Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure.
- Coronary angioplasty of the target SVG in the past.
- Cardiogenic shock .
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- Remaining lesion (s) with a treatment planned within the following year.
- Pregnancy.
- Contraindication to aspirin and/or clopidogrel treatment.
- Allergy to paclitaxel.
- Any disease with a limiting life-expectancy (to less than 2 years).
- Definite presence or high suspicion of thrombus or ulceration in the target lesion.
- Target lesion located in the same SVG than the culprit lesion (if present) and the distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion is < 4 cm.
- Vein graft diameter < 2.5 mm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sealing Moderate Coronary Saphenous VEin Graft LEsions With the Paclitaxel-eluting Stent (Taxus) as a New Approach to Maintain Vein Graft Patency and Reduce Cardiac Events: a Pilot Intravascular Ultrasound Study.
HYPOTHESIS
- Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS.
- Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.
OBJECTIVES
- To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
- To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
Read the detailed description
This will be a prospective randomized study assessing the efficacy of stenting moderate SVG lesions with the taxus stent in the prevention of atherosclerosis progression of SVGs as evaluated by IVUS. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. The use of a filter wire during dilation will be strongly recommended. Following this procedure, all patients will have clinical controls at 1 month and at 6 months and an angiographic and IVUS control study at 1 year follow-up.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- Paclitaxel eluting stent
- Keywords
- Coronary Artery Bypass Grafting, Drug Eluting Stent, Saphenous Vein Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel eluting stentDevice
Also called Taxus (paclitaxel eluting stent)
Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| PCI-stenting | Experimental | Stenting the moderate SVG lesion with the paclitaxel stent Receives: Device: Paclitaxel eluting stent |
| Standard medical treatment | Other | Not described Receives: Device: Paclitaxel eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
Measured: 12 months
Change between baseline and follow-up in ultrasound lumen area and minimal lumen diameter (% and absolute value) at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
Measured: 12 months
Change in atheroma volume (% and absolute value) as evaluated by IVUS between baseline and follow-up in an angiographically non-diseased 40 mm segment (excluding the target lesion), comparing stented vs medically treated SVGs
Measured: 12 months
Secondary outcomes (2)
Cumulative incidence of clinical events (cardiovascular death, myocardial infarction, repeat revascularization) at 12 months follow-up
Measured: 12 months
SVG occlusion rate, lesion/stent late loss, minimal lumen diameter, and % diameter stenosis as assessed by angiography at 12 months follow-up
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 posted10 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Josep Rodes-Cabau, MD, Principal investigator, Laval Hospital Research CenterOlivier F Bertrand, MD, PhD, Principal investigator, Laval Hospital Research CenterRobert Delarocheliere, MD, Principal investigator, Laval Hospital Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289835
- Sponsor's protocol ID
- Laval-VG-01
- Acronym
- VELETI
- Status last verified
- Oct 2008
- First submitted
- 9 Feb 2006
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Urena M, Jerez M, Nombela-Franco L, Ribeiro HB, Allende R, Proulx G, Nguyen CM, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Cote M, Despres JP, Dagenais GR, DeLarochelliere R. Five-year follow-up of the plaque sealing with paclitaxel-eluting stents vs medical therapy for the treatment of intermediate nonobstructive saphenous vein graft lesions (VELETI) trial. Can J Cardiol. 2014 Jan;30(1):138-45. doi: 10.1016/j.cjca.2013.11.002. Epub 2013 Nov 6.
PubMed 24365196Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Bagur R, Proulx G, Nguyen CM, Cote M, Landcop MC, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Courtis J, Dagenais GR, Despres JP, DeLarochelliere R. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions: the moderate vein graft lesion stenting with the taxus stent and intravascular ultrasound (VELETI) pilot trial. Circulation. 2009 Nov 17;120(20):1978-86. doi: 10.1161/CIRCULATIONAHA.109.874057. Epub 2009 Nov 2.
PubMed 19884468
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sealing Moderate Coronary Saphenous VEin Graft LEsions With the Paclitaxel-eluting Stent (Taxus) as a New Approach to Maintain Vein Graft Patency and Reduce Cardiac Events: a Pilot Intravascular Ultrasound Study.
- ClinicalTrials.gov ID
- NCT00289835
- Acronym / sponsor ID
- VELETI / Laval-VG-01
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- Coronary Artery Bypass Grafting, Drug Eluting Stent, Saphenous Vein Graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Feb 2006 (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.
HYPOTHESIS
- Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS.
- Sealing moderate SVG lesions with the TAXUS stent does not accelerate SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.
OBJECTIVES
- To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
- To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
Detailed description
This will be a prospective randomized study assessing the efficacy of stenting moderate SVG lesions with the taxus stent in the prevention of atherosclerosis progression of SVGs as evaluated by IVUS. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. The use of a filter wire during dilation will be strongly recommended. Following this procedure, all patients will have clinical controls at 1 month and at 6 months and an angiographic and IVUS control study at 1 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI-stenting | Experimental | Device: Paclitaxel eluting stentStenting the moderate SVG lesion with the paclitaxel stent |
| Standard medical treatment | Other | Device: 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 (4 listed)
- Written and signed informed consent.
- Patients ≥18 years old.
- Clinical indication for cardiac catheterization and SVG angiography.
- Presence of at least one SVG lesion of 30% to 70% diameter stenosis by visual estimation which is (are) not the culprit lesion (s) responsible for the clinical syndrome of the patient.
Key exclusion criteria (14 listed)
- Ejection fraction <20%.
- Renal insufficiency with creatinine > 250 mg/dl.
- Presence of more than 3 moderate SVG stenosis or significant diffuse SVG disease.
- Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure.
- Coronary angioplasty of the target SVG in the past.
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 |
|---|---|---|
| Paclitaxel eluting stentAlso: Taxus (paclitaxel eluting stent)Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment | Device | PCI-stenting, Standard medical treatment |
Primary outcome
Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
Time frame: 12 months
Change between baseline and follow-up in ultrasound lumen area and minimal lumen diameter (% and absolute value) at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions
Time frame: 12 months
Change in atheroma volume (% and absolute value) as evaluated by IVUS between baseline and follow-up in an angiographically non-diseased 40 mm segment (excluding the target lesion), comparing stented vs medically treated SVGs
Time frame: 12 months
2 secondary outcomes
Cumulative incidence of clinical events (cardiovascular death, myocardial infarction, repeat revascularization) at 12 months follow-up
Time frame: 12 months
SVG occlusion rate, lesion/stent late loss, minimal lumen diameter, and % diameter stenosis as assessed by angiography at 12 months follow-up
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 24 Nov 2011.
- Derived from this study: PubMed 24365196Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Urena M, Jerez M, Nombela-Franco L, Ribeiro HB, Allende R, Proulx G, Nguyen CM, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Cote M, Despres JP, Dagenais GR, DeLarochelliere R. Five-year follow-up of the plaque sealing with paclitaxel-eluting stents vs medical therapy for the treatment of intermediate nonobstructive saphenous vein graft lesions (VELETI) trial. Can J Cardiol. 2014 Jan;30(1):138-45. doi: 10.1016/j.cjca.2013.11.002. Epub 2013 Nov 6.
- Derived from this study: PubMed 19884468Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Bagur R, Proulx G, Nguyen CM, Cote M, Landcop MC, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Courtis J, Dagenais GR, Despres JP, DeLarochelliere R. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions: the moderate vein graft lesion stenting with the taxus stent and intravascular ultrasound (VELETI) pilot trial. Circulation. 2009 Nov 17;120(20):1978-86. doi: 10.1161/CIRCULATIONAHA.109.874057. Epub 2009 Nov 2.
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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.
Josep Rodes-Cabau, MD principal investigator
Laval Hospital Research Center
Olivier F Bertrand, MD, PhD principal investigator
Laval Hospital Research Center
Robert Delarocheliere, MD principal investigator
Laval Hospital Research Center
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 Paclitaxel eluting stent in people with Coronary Artery Bypass Grafting, run by Laval University at 1 site in Canada.
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 4 inclusion and 14 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 24 Nov 2011. 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 Canada. 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?
Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT00289835, which also lists 2 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 24 Nov 2011.