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Coronary Artery DiseasePhase 2/3TAXUS VINCT00297804

A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions

A Phase 2/3 study testing TAXUS Express Paclitaxel-Eluting Coronary Stent System in people with Coronary Artery Disease, run by Boston Scientific Corporation at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
TAXUS Express Paclitaxel-Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
448 participants
Where
1 siteGermany
Study dates
May 2002to Feb 2008
Phase
Phase 2/3
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

  • General Inclusion Criteria
  • Patient >or= 18 years old
  • Eligible for percutaneous coronary intervention
  • Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
  • Acceptable candidate for CABG
  • Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
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  • Willing to comply with all specified follow-up evaluations
  • Angiographic Inclusion Criteria
  • Target lesion located within a single native coronary vessel
  • Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by up to 2 study stents (maximum allowable stent length of 48 mm).
  • Cumulative target lesion length is >or= 18 mm and <or= 40 mm (visual estimate)
  • RVD of >or= 2.5 mm to <or= 3.75 mm (visual estimate)
  • Target lesion diameter stenosis >or=50% (visual estimate)
  • Target lesion is de novo

Who cannot join

  • General Exclusion Criteria:
  • Known sensitivity to paclitaxel
  • Any previous or planned treatment with any anti-restenotic drug-coated or drug-eluting coronary stent (Note: previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as the procedure with the stent meets the protocol defined criteria for staged procedures)
  • Previous or planned treatment with intravascular brachytherapy in the target vessel
  • MI within 72 hours prior to the study procedure and/or CK-MB >2x the local laboratory's upper limits of normal (refers to a measured value on the day of the study procedure)
  • Left ventricular ejection fraction <25%
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  • Cerebrovascular Accident within the past 6 months
  • Acute or chronic renal dysfunction (creatinine >1.7 mg/dl or >150 µmol/L)
  • Contraindication to ASA, or to both clopidogrel and ticlopidine
  • Leukopenia (leukocyte count <3.5 x 109/liter)
  • Thrombocytopenia (platelet count <100,000/mm3)
  • Active peptic ulcer or active gastrointestinal bleeding
  • Known allergy to stainless steel
  • Any prior true anaphylactic reaction to contrast agents
  • Known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the study procedure
  • Patient is currently taking colchicine
  • Patient is currently, or has been treated with paclitaxel within 12 months of the study procedure
  • Female of childbearing potential with a positive pregnancy test within 7 days before the study procedure, or lactating, or intends to become pregnant during the study
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
  • Angiographic Exclusion Criteria
  • Left main coronary artery disease (stenosis >50%), whether protected or unprotected
  • Target lesion is ostial in location (within 3.0 mm of vessel origin)
  • Target lesion(s) and/or target vessel proximal to the target lesion(s) is moderately or severely calcified by visual estimation
  • Target lesion is located within or distal to a >60°bend in the vessel
  • Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter
  • Target lesion is totally occluded Thrombolysis in MI (TIMI flow <or= 1)
  • Angiographic presence of probable or definite thrombus
  • Target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • HELIOS Clinic

    Siegburg, 53721

Other trials in Germany

About this study

Official title: TAXUS VI - A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions

The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate rate-release formulation of triblock copolymer carrier system in patients with a higher risk of target lesion revascularisation and restenosis.

Read the detailed description

The ultimate goal of a paclitaxel eluting stent system is to prevent restenosis by blunting the initial response to stent implant injury and sustaining the arrested response until vascular healing has taken place.

The purpose of the TAXUS VI trial is to study the safety and efficacy of the TAXUS(TM)Stent under controlled trial circumstances and targets patients with a higher risk of target lesion revascularisation and restenosis. The study population will include longer lesions, smaller diameter vessels, multiple lesions in the same vessel, and allows for the use of up to 2 randomized study stents.

The clinical investigation will evaluate the safety and effectiveness of the TAXUS(TM)Stent with 1 µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate rate-release formulation of a triblock copolymer carrier system for treatment of de novo coronary artery lesions.

Patients are stratified by site and presence or absence of medically treated diabetes mellitus and then randomized to receive either the TAXUS(TM)Stent or the uncoated EXPRESS(TM)stent.

The primary objective of the study is to show superior 9-month target vessel revascularization (TVR) rate for TAXUS(TM) Stent compared to uncoated Express(TM)control stent.

Being tested
TAXUS Express Paclitaxel-Eluting Coronary Stent System, Control stent
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Stent Implant, Drug-coated Stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAXUS Express Paclitaxel-Eluting Coronary Stent SystemDevice

    Paclitaxel-Eluting Coronary Stent System

  • Control stentDevice

    control stent

Study groups in NCT00297804
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Device: TAXUS Express Paclitaxel-Eluting Coronary Stent System
Arm 2Active comparatorNot described
Receives: Device: Control stent

What is being measured

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

  1. Rate of TVR 9 months after index procedure

    Measured: 9 Months

Secondary outcomes (7)

  1. • Rates of composite Major Adverse Cardiac Events (MACE) and the individual components of MACE, assessed at 1, 3, 6 and 9 months after the study procedure and annually for 5 years (i.e., 1, 2, 3, 4, and 5 years after the study procedure).

    Measured: 5 years

  2. Stent thrombosis rate.

    Measured: 5 Years

  3. Target Vessel Failure.

    Measured: 5 years

  4. Clinical procedural success.

    Measured: Post procedure

  5. Binary restenosis rate.

    Measured: 9 months

  6. • Additional angiographic endpoints at 9 month angiographic follow-up

    Measured: 9 months

  7. IVUS assessment in a subset of approximately 200 patients. At the baseline procedure (post-procedural) and at 9 month follow-up the absolute neointimal volume and the change in neointimal volume from post-procedure to follow-up will be analysed.

    Measured: 9 months

Timeline

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

  1. First posted1 Mar 2006 (estimated)
  2. Study startMay 2002
  3. Primary completionOct 2003
  4. Study completionFeb 2008

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297804
Sponsor's protocol ID
S2009
Other IDs
TAXUS VI
Acronym
TAXUS VI
Status last verified
Apr 2017
First submitted
27 Feb 2006
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wakabayashi K, Mintz GS, Weissman NJ, Stone GW, Ellis SG, Grube E, Ormiston JA, Turco MA, Pakala R, Xue Z, Desale S, Laynez-Carnicero A, Romaguera R, Sardi G, Pichard AD, Waksman R. Impact of drug-eluting stents on distal vessels. Circ Cardiovasc Interv. 2012 Apr;5(2):211-9. doi: 10.1161/CIRCINTERVENTIONS.111.965780. Epub 2012 Apr 10.

    PubMed 22496083

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TAXUS Express Paclitaxel-Eluting Coronary Stent System in people with Coronary Artery Disease, run by Boston Scientific Corporation at 1 site in Germany.

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 14 inclusion and 30 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 21 Apr 2017. 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 Germany. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Rate of TVR 9 months after index procedure (time frame: 9 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 NCT00297804, 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 21 Apr 2017.

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