AzTrials
AzTrials

Coronary StenosisPhase 2/3NCT00301522

Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions

A Phase 2/3 study testing TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation and Express2 in people with Coronary Stenosis, run by Boston Scientific Corporation at 72 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis
What is being tested?
TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation and Express2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,108 participants
Where
72 sitesUnited States
Study dates
Feb 2003to Apr 2009
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

  • Patient was ≥ 18 years old.
  • Eligible for percutaneous coronary intervention.
  • Documented stable angina pectoris.
  • LVEF of greater than 25%.
  • Acceptable candidate for coronary artery bypass grafting.
  • Target lesion segment is located within a single native coronary vessel.
Show all 11Show fewer
  • Target lesion was de novo.
  • RVD was greater than 2.25 mm and less than 4.0 mm .and patient and/or lesion fulfilled protocol defined subgroups.
  • Cumulative target lesion length was greater than 10 mm and less than 46mm assessed after pre-dilatation with standard balloon or cutting balloon angioplasty, including adjacent areas of dissection that were covered.
  • Target lesion diameter stenosis less than 50% before pre-dilatation .
  • Vessel and lesion morphology such that the lesion was treated only with study stent(s); no planned use of commercial stents.

Who cannot join

  • Known hypersensitivity to paclitaxel.
  • Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
  • Planned use of both the study stent and a non-study stent in the treatment of the target vessel.
  • Previous or planned treatment with intravascular brachytherapy in the target vessel.
  • Recent MI.
  • CK-MB greater than 2x the local laboratory's upper limit of normal.
Show all 29Show fewer
  • Cerebrovascular accident within 6 months of randomization.
  • Planned CABG ≤ 9 months post index procedure.
  • Acute or chronic renal dysfunction.
  • Leukopenia.
  • Thrombocytopenia or thrombocytosis.
  • Active peptic ulcer or active gastrointestinal bleeding, or previously active within 6 months.
  • Known allergy to stainless steel.
  • Any prior true anaphylactic reaction to contrast agents.
  • Contraindication to ASA or to both clopidogrel and ticlopidine.
  • Patient was on warfarin or it was anticipated that treatment with warfarin would have been required during any period within 6 months post the index procedure.
  • Patient was or had been treated with chemotherapeutic agents within 12 months of the index procedure.
  • Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure.
  • Male or female with known intention to procreate within 3 months post index procedure.
  • Co-morbid condition(s) that could limit the patient's ability to participate in the study, limit compliance with follow-up requirements or impact the scientific integrity of the study.
  • Planned surgical procedure requiring withdrawal of any anti-platelet therapy within 6 months post index procedure.
  • 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.
  • Unprotected left main coronary artery disease.
  • Target lesion was ostial in location.
  • Target lesion and/or target vessel proximal to the target lesion was moderately or severely calcified.
  • Target lesion was located within or distal to a > 60° bend in the vessel.
  • Side branch of the target lesion included ostial narrowing ≥ 50% DS and was ≥ 2.0 mm diameter.
  • Target lesion was totally occluded.
  • Angiographic presence of probable or definite thrombus.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

United States72 sites

  • Albany Medical Center/Capital Cardiovascular Associates

    Albany, New York, 12208

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • St. Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Palm Beach Heart Research Institute, LLC

    Atlantis, Florida, 33462

  • Aurora Denver Cardiology

    Aurora, Colorado, 80012

  • South Austin Hospital/Capital Cardiovascular Specialists

    Austin, Texas, 78745

  • Baptist Medical Center Princeton

    Birmingham, Alabama, 35211

  • Cardiovascular Associates PC/Baptist Medical Center Montclair

    Birmingham, Alabama, 35213

  • UAB Interventional Cardiology

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Buffalo General Hospital

    Buffalo, New York, 14215

  • Lahey Clinic Hospital

    Burlington, Massachusetts, 01805

  • Mid-Carolina Cardiology Research Division/Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • MidWest Cardiology Research Foundation/Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • St. John's Hospital and Medical Center

    Detroit, Michigan, 48236

  • North Ohio Research, Ltd

    Elyria, Ohio, 44035

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Texas Houston Hermann Hospital

    Houston, Texas, 77030

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Scripps Memorial Hospital LaJolla

    La Jolla, California, 92037

  • St. Mary's Medical Center

    Langhorne, Pennsylvania, 19047

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Midwest Heart Foundation

    Lombard, Illinois, 60148

  • Miami International Cardiology Consultants

    Miami Beach, Florida, 33137

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10021

  • Lenox Hill Hospital

    New York, New York, 10021

  • New York Presbyterian Hospital

    New York, New York, 10021

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Mediquest Research Group, Inc.

    Ocala, Florida, 34471

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Cardiac & Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • Arizona Heart Institute and Hospital

    Phoenix, Arizona, 85006

  • Maine Medical Center

    Portland, Maine, 04102

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Wake Heart Research

    Raleigh, North Carolina, 27610

  • Mayo Clinic/Saint Mary's Hospital

    Rochester, Minnesota, 55902

  • Rochester General Hospital

    Rochester, New York, 14641

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • The Heart & Vascular Institute of Florida

    Safety Harbor, Florida, 34695

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Medical Center

    Stanford, California, 94305

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: TAXUS V: De Novo Lesion: A Randomized, Double-blind Trial to Assess TAXUS Paclitaxel-Eluting Coronary Stents, SR Formulation, in the Treatment of De Novo Coronary Lesions

The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions

Read the detailed description

The primary endpoint is the incidence rate of TVR through 9 months post index procedure. In this protocol, TVR must be ischemia driven, based on the presence of symptoms, positive functional testing or Quantitative Coronary Angiography (QCA) severity of restenosis.

Secondary endpoints include the following:

  • Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure).
  • Stent thrombosis rate.
  • TVF.
  • Clinical procedural success and technical success.
  • Binary restenosis rate.
  • Additional angiographic endpoints to be measured in all patients with 9 month angiographic follow-up include:
  • Absolute lesion length
  • Reference Vessel Diameter (RVD)
  • Minimum Lumen Diameter (MLD)
  • Percent diameter stenosis (% DS)
  • Acute gain
  • Late loss
  • Loss index
  • Patterns of recurrent restenosis, including edge effect
  • Coronary aneurysm
  • IVUS Substudy
  • Identification of potential safety issues, i.e., incomplete stent apposition.
  • change in neointimal volume from post procedure to follow-up
  • change in MLD within stent
  • minimum lumen area (MLA) within stent
  • lumen, plaque and vessel measurements at the stent edges (outside stent)
Being tested
TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation, Express2
Keywords
Coronary, Artery, Stenosis, Drug-eluting, stent, restenosis, revascularization
Medical subject headings
Coronary Stenosis, Constriction, Pathologic

What participants receive

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

  • TAXUS Paclitaxel-Eluting Coronary Stent, Slow-FormulationDevice

    Paclitaxel-Eluting Coronary Stent, Slow-Formulation

  • Express2Device

    Coronary Stent System

Study groups in NCT00301522
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Device: TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation
Arm 2Active comparatorNot described
Receives: Device: Express2

What is being measured

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

  1. Incidence rate of TVR through 9 months post index procedure

    Measured: 9 Months

Secondary outcomes (19)

  1. • Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure).

    Measured: 5 Years

  2. Stent thrombosis rate

    Measured: 5 Years

  3. Target Vessel Failure

    Measured: 5 Years

  4. Clinical procedural success and technical success

    Measured: 5 years

  5. Binary restenosis rate.

    Measured: 5 Years

  6. Absolute lesion length

    Measured: 9 Months

  7. Reference Vessel Diameter (RVD)

    Measured: 9 Months

  8. Minimum Lumen Diameter (MLD)

    Measured: 9 Months

  9. Percent diameter stenosis (% DS)

    Measured: 9 Months

  10. Acute gain

    Measured: 9 Months

  11. Late loss

    Measured: 9 Months

  12. Loss index

    Measured: 9 Months

  13. Patterns of recurrent restenosis, including edge effect

    Measured: 9 Months

  14. Coronary aneurysm

    Measured: 9 Months

  15. Identification of potential safety issues, i.e., incomplete stent apposition.

    Measured: 9 Months

  16. change in neointimal volume from post procedure to follow-up

    Measured: 9 Months

  17. change in MLD within stent

    Measured: 9 Months

  18. minimum lumen area (MLA) within stent

    Measured: 9 Months

  19. lumen, plaque and vessel measurements at the stent edges (outside stent)

    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 posted13 Mar 2006 (estimated)
  2. Study startFeb 2003
  3. Primary completionDec 2004
  4. Study completionApr 2009

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
1,108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301522
Sponsor's protocol ID
TAXUS V De novo
Other IDs
S5442
Status last verified
Aug 2010
First submitted
9 Mar 2006
Last updated
6 Aug 2010
Results posted
No
Data monitoring committee
No

Publications

  • Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME; TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1215-23. doi: 10.1001/jama.294.10.1215.

    PubMed 16160130

  • 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

  • Doi H, Maehara A, Mintz GS, Yu A, Wang H, Mandinov L, Popma JJ, Ellis SG, Grube E, Dawkins KD, Weissman NJ, Turco MA, Ormiston JA, Stone GW. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxel-eluting stents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. JACC Cardiovasc Interv. 2009 Dec;2(12):1269-75. doi: 10.1016/j.jcin.2009.10.005.

    PubMed 20129555

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation and Express2 in people with Coronary Stenosis, run by Boston Scientific Corporation at 72 sites 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 11 inclusion and 29 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 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites 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 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?

Incidence rate of TVR through 9 months post 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 NCT00301522, which also lists 3 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 6 Aug 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in