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Coronary RestenosisPhase 2/3TAXUS V ISRNCT00287573

Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

A Phase 2/3 study testing TAXUS Express2 and Brachytherapy (beta source) in people with Coronary Restenosis, run by Boston Scientific Corporation at 42 sites in 2 countries.

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 objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent restenosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Restenosis
What is being tested?
TAXUS Express2 and Brachytherapy (beta source)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
42 sitesin 2 countries
Study dates
Jun 2003to Jan 2010
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

  • Cumulative target lesion length is </= 46 mm (visual estimate).
  • Reference vessel diameter (RVD) is >/= 2.5 and </= 3.75 mm (visual estimate)
  • Left ventricular ejection fraction (LVEF) is >/= 25%

Who cannot join

  • Any previous or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent in the target vessel. (Note:previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as, the procedure with the non-study stent meets the protocol defined criteria for non-target lesion interventions.)
  • Previous or planned treatment with intra-coronary brachytherapy (gamma or beta source) in the target vessel
  • Previous external radiotherapy to the heart or target vessel area
  • Known genetic radiation sensitivity disorders (i.e. ataxia-telangiectasia, etc.)
  • Side branch of the target lesion includes ostial narrowing >/= 50% diameter stenosis (DS) and is >/= 2.0 mm diameter
  • Target lesion has been previously treated for ISR with the placement of a second stent(s), which covers >/= 50% of the original stent length (a true "stent sandwich")
Show all 12Show fewer
  • Target vessel is pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, or transluminal extraction catheter immediately prior to delivery of randomized treatment (stent placement or intra-coronary brachytherapy)
  • Recent myocardial infarction (MI) (symptom onset </= 72 hours prior to randomization)
  • CK-MB >2x the local laboratory's upper limit of normal (ULN) (refers to a measured value on the day of the index procedure as drawn per protocol)
  • Anticipated treatment with warfarin during any period in the 6 months post index procedure
  • Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure
  • Planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target lesion

Trial locations and contacts

42 sites in 2 countries.

42 sites in 2 countries

United States40 sites

  • Albany Medical Center/Capital Cardiovascular Associates

    Albany, New York, 12208

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Aurora Denver Cardiology

    Aurora, Colorado, 80012

  • South Austin Hospital/Capital Cardiovascular Specialists

    Austin, Texas, 78745

  • Baptist Medical Center Princeton

    Birmingham, Alabama, 35211

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • 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

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • North Ohio Research, Ltd

    Elyria, Ohio, 44035

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • LeBauer Cardiovascular Research Foundation

    Greensboro, North Carolina, 27401

  • The Methodist Hospital Research Institute in Cardiovascular Interventions

    Houston, Texas, 77030

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • St. Mary's Medical Center

    Langhorne, Pennsylvania, 19047

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407-1195

  • 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

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Cardiac & Vascular Research Center of Northern Michigan

    Petoskey, Michigan, 49770

  • Maine Medical Center

    Portland, Maine, 04102

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Mercy General Hospital

    Sacramento, California, 95819

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Medical Center

    Stanford, California, 94305

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912-6367

  • 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

Canada2 sites

  • Sunnybrook & Women's College Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis

The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent restenosis.

Read the detailed description

Percutaneous approaches to in-stent restenosis (ISR) have included balloon angioplasty alone, rotational atherectomy, cutting balloon angioplasty, directional coronary atherectomy, excimer laser angioplasty, placement of a second stent or any combination thereof, and intra-coronary brachytherapy. Of these, only brachytherapy has been shown to reduce recurrent restenosis after PCI for ISR, - and is now considered the standard of care. Logistical considerations in establishing and maintaining a radiation program have limited the widespread availability of this modality. These considerations include the need for involvement of radiation oncologists, physicists, and safety officers; nuclear licensing requirements; need for increased shielding and safety training; equipment and procedural complexities; as well as increased procedural time and costs. Furthermore, recurrent ISR after brachytherapy may still occur. Stent based drug delivery for the treatment of ISR holds promise as a much simpler, safer and potentially more effective alternative to brachytherapy.

This is a prospective, randomized (1:1), open-label, multicenter, safety and efficacy trial for the treatment of in-stent restenosis. The primary objective is to demonstrate a superior or non-inferior 9-month target vessel revascularization (TVR) rate for TAXUS-SR stent compared to intra-coronary brachytherapy (beta source).

Being tested
TAXUS Express2, Brachytherapy (beta source)
Medical subject headings
Coronary Restenosis

What participants receive

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

  • TAXUS Express2Device

    Paclitaxel-Eluting Coronary Stent System

  • Brachytherapy (beta source)Procedure or surgery

    Brachytherapy (beta source)

Study groups in NCT00287573
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Device: TAXUS Express2
Arm 2Active comparatorNot described
Receives: Procedure: Brachytherapy (beta source)

What is being measured

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

  1. Rate of Target Vessel Revascularization

    Measured: 9 Months

Secondary outcomes (20)

  1. Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE

    Measured: assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years

  2. Stent thrombosis rate

    Measured: 5 Years

  3. Target Vessel Failure (TVF, defined as any ischemia-driven revascularization of the target vessel, MI related to the target vessel, or death related to the target vessel).

    Measured: 5 Years

  4. Clinical procedural success and technical success

    Measured: 5 Years

  5. Binary restenosis rate

    Measured: 5 years

  6. Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm

    Measured: 5 Years

  7. Absolute lesion length

    Measured: 9 Months

  8. Reference Vessel Diameter (RVD)

    Measured: 9 Months

  9. Minimum Lumen Diameter (MLD)

    Measured: 9 Months

  10. Percent diameter stenosis (% DS)

    Measured: 9 Months

  11. Acute gain

    Measured: 9 Months

  12. Late loss

    Measured: 9 Months

  13. Loss index

    Measured: 9 Months

  14. Patterns of recurrent restenosis, including edge effect

    Measured: 9 Months

  15. Coronary aneurysm

    Measured: 9 Months

  16. Identification of potential safety issues.

    Measured: 9 Months

  17. Change in neointimal volume from post procedure to follow-up

    Measured: 9 Months

  18. Change in MLD within the stent or area of brachytherapy

    Measured: 9 Months

  19. Minimum lumen area (MLA) within the stent or area of brachytherapy

    Measured: 9 Months

  20. Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)

    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 posted7 Feb 2006 (estimated)
  2. Study startJun 2003
  3. Primary completionDec 2004
  4. Study completionJan 2010

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
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287573
Sponsor's protocol ID
S5442
Other IDs
TAXUS V ISR
Acronym
TAXUS V ISR
Status last verified
Aug 2010
First submitted
3 Feb 2006
Last updated
6 Aug 2010
Results posted
No

Publications

  • Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12.

    PubMed 16531618

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TAXUS Express2 and Brachytherapy (beta source) in people with Coronary Restenosis, run by Boston Scientific Corporation at 42 sites in 2 countries.

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 3 inclusion and 12 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 42 sites in United States, 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 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 Target Vessel Revascularization (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 NCT00287573, 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 6 Aug 2010.

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