Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)
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ClinicalTrials.gov Identifier: NCT01223443 |
Recruitment Status :
Terminated
(The trial was prematurely stopped due to slow patient enrolment.)
First Posted : October 19, 2010
Last Update Posted : October 27, 2016
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Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up.
Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Bypass Grafting | Device: Paclitaxel eluting stent | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents as a New Approach to MainTaining VeIn Graft Patency and Reducing Cardiac Events |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: PCI-stenting
Stenting the moderate SVG lesion with the paclitaxel stent
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Device: Paclitaxel eluting stent
Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment |
No Intervention: Standard medical treatment |
- The first occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization related to the target SVG over the duration of follow-up. [ Time Frame: 60 months ]
- 1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up. [ Time Frame: 60 months ]
- 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome. [ Time Frame: 60 months ]
- 3-Total medical costs (at index hospitalization and at follow-up). [ Time Frame: 60 months ]
- 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented. [ Time Frame: 60 months ]
- 5-Severe (>60%) SVG lesions or SVG occlusion at the target SVG at 2-year follow-up as determined by 3D computed-tomography. [ Time Frame: 60 months ]
- 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up. [ Time Frame: 60 months ]
- 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria. [ Time Frame: 60 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical indication for cardiac catheterization and SVG angiography
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Presence of at least one SVG lesion of 30% to 60% diameter stenoses, by visual estimation, which is not the culprit lesion* responsible for the clinical syndrome of the patient
*If the target lesion is located in the same SVG than the culprit lesion (if present) it has to be at least 4 cm far from the stented segment)
- Written informed consent
Exclusion Criteria:
- Patient < 18 years old
- Ejection fraction < 30%
- Renal insufficiency with creatinine > 200 μmol/l
- Presence of more than 2 moderate SVG stenoses in a single SVG or significant diffuse SVG disease defined as disease covering more than half of the length of the SVG
- Presence of more than 2 SVGs with moderate SVG stenoses
- Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure (culprit lesions will be treated before patient randomization)
- Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
- SVG lesion located at the distal anastomosis
- SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium)
- Lesion length >25 mm
- SVGs ≤ 3 years ago
- Cardiogenic shock
- Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
- Pregnancy
- Contraindication to aspirin and/or thienopyridine/ticagrelor treatment
- Allergy to paclitaxel
- Any disease with a limiting life-expectancy (less than 2 years)
- Need for chronic anticoagulation treatment
- Definite presence or high suspicion of thrombus or ulceration in the target lesion
- Target lesion located in the same SVG as the culprit lesion (if present) and distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion < 4 cm
- Vein graft diameter < 2.5 mm

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223443
Canada | |
Institut universitaire de cardiologie et de pneumologie de Québec | |
Quebec, Canada, G1V 4G5 |
Principal Investigator: | Josep Rodes-Cabau, MD | Institut universitaire de cardiologie et de pneumologie de Québec |
Responsible Party: | Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
ClinicalTrials.gov Identifier: | NCT01223443 |
Other Study ID Numbers: |
VELETI II |
First Posted: | October 19, 2010 Key Record Dates |
Last Update Posted: | October 27, 2016 |
Last Verified: | October 2016 |
Coronary Artery Bypass Grafting Drug Eluting Stent Saphenous Vein Graft |
Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |