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Coronary Artery Bypass GraftingPhase 4VELETI IINCT01223443

Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents

A Phase 4 study testing Paclitaxel eluting stent in people with Coronary Artery Bypass Grafting, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up. 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
125 participants
Where
1 siteCanada
Study dates
Apr 2010to Sep 2016
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

  • Clinical indication for cardiac catheterization and SVG angiography
  • 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

Who cannot join

  • 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)
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

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

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.

Read the detailed description

This is a prospective, multicenter, randomized study assessing the efficacy of stenting moderate SVG lesions (30% to 60% by visual estimation) with paclitaxel-eluting stents in the prevention of SVG atherosclerosis progression and cardiac events at follow-up. 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. Following this procedure, all patients will have follow-up visits by telephone or clinic at 30 days, 180 days, 1 year, and yearly until the common study end date. The duration of the study will be approximately 4 years with a minimun of 2-year follow-up.

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

    Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment

Study groups in NCT01223443
Study groupRoleWhat they receive
PCI-stentingExperimentalStenting the moderate SVG lesion with the paclitaxel stent
Receives: Device: Paclitaxel eluting stent
Standard medical treatmentNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 60 months

Secondary outcomes (7)

  1. 1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up.

    Measured: 60 months

  2. 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome.

    Measured: 60 months

  3. 3-Total medical costs (at index hospitalization and at follow-up).

    Measured: 60 months

  4. 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented.

    Measured: 60 months

  5. 5-Severe (>60%) SVG lesions or SVG occlusion at the target SVG at 2-year follow-up as determined by 3D computed-tomography.

    Measured: 60 months

  6. 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up.

    Measured: 60 months

  7. 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionAug 2015
  4. Study completionSep 2016

Why it stopped: The trial was prematurely stopped due to slow patient enrolment.

Resources

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
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01223443
Sponsor's protocol ID
VELETI II
Acronym
VELETI II
Status last verified
Oct 2016
First submitted
18 Oct 2010
Last updated
27 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Rodes-Cabau J, Jolly SS, Cairns J, Mansour S, L'Allier PL, Teefy PJ, Graham JJ, Le May MR, Cantor WJ, Wood D, Balasubramanian K, DeLarochelliere R, Dzavik V; VELETI II Investigators (Sealing Moderate Coronary Saphenous Vein Graft Lesions With Paclitaxel-Eluting Stents). Sealing Intermediate Nonobstructive Coronary Saphenous Vein Graft Lesions With Drug-Eluting Stents as a New Approach to Reducing Cardiac Events: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2016 Nov;9(11):e004336. doi: 10.1161/CIRCINTERVENTIONS.116.004336.

    PubMed 27815344

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 Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec 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 21 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: stopped early, as of the sponsor's last update on 27 Oct 2016. 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 was stopped early (reason given: The trial was prematurely stopped due to slow patient enrolment.). Results are not available in the source record.

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 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). 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 NCT01223443, 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 27 Oct 2016.

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