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

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00287573
Collaborator
(none)
488
Enrollment
42
Locations
2
Arms
79
Duration (Months)
11.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: TAXUS Express2
  • Procedure: Brachytherapy (beta source)
 Phase 2/Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
488 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Dec 1, 2004
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Device: TAXUS Express2
Paclitaxel-Eluting Coronary Stent System
Active Comparator: Arm 2

Procedure: Brachytherapy (beta source)
Brachytherapy (beta source)

Outcome Measures

Primary Outcome Measures

  1. Rate of Target Vessel Revascularization [9 Months]

Secondary Outcome Measures

  1. Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE [assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years]

  2. Stent thrombosis rate [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). [5 Years]

  4. Clinical procedural success and technical success [5 Years]

  5. Binary restenosis rate [5 years]

  6. Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm [5 Years]

  7. Absolute lesion length [9 Months]

  8. Reference Vessel Diameter (RVD) [9 Months]

  9. Minimum Lumen Diameter (MLD) [9 Months]

  10. Percent diameter stenosis (% DS) [9 Months]

  11. Acute gain [9 Months]

  12. Late loss [9 Months]

  13. Loss index [9 Months]

  14. Patterns of recurrent restenosis, including edge effect [9 Months]

  15. Coronary aneurysm [9 Months]

  16. Identification of potential safety issues. [9 Months]

  17. Change in neointimal volume from post procedure to follow-up [9 Months]

  18. Change in MLD within the stent or area of brachytherapy [9 Months]

  19. Minimum lumen area (MLA) within the stent or area of brachytherapy [9 Months]

  20. Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy) [9 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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")

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Medical Center Princeton Birmingham Alabama United States 35211
2 Scripps Green Hospital LaJolla California United States 92037
3 Mercy General Hospital Sacramento California United States 95819
4 Stanford Medical Center Stanford California United States 94305
5 Aurora Denver Cardiology Aurora Colorado United States 80012
6 Washington Hospital Center Washington District of Columbia United States 20010
7 Florida Hospital Orlando Florida United States 32803
8 Piedmont Hospital Atlanta Georgia United States 30309
9 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
10 Maine Medical Center Portland Maine United States 04102
11 Washington Adventist Hospital Takoma Park Maryland United States 20912-6367
12 Tufts Medical Center Boston Massachusetts United States 02111
13 Lahey Clinic Hospital Burlington Massachusetts United States 01805
14 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
15 Spectrum Health Hospitals Grand Rapids Michigan United States 49503
16 Cardiac & Vascular Research Center of Northern Michigan Petoskey Michigan United States 49770
17 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407-1195
18 Saint Luke's Hospital Kansas City Missouri United States 64111
19 Barnes Jewish Hospital St. Louis Missouri United States 63110
20 Nebraska Heart Institute Lincoln Nebraska United States 68526
21 Albany Medical Center/Capital Cardiovascular Associates Albany New York United States 12208
22 Buffalo General Hospital Buffalo New York United States 14215
23 Columbia University Medical Center New York New York United States 10021
24 Lenox Hill Hospital New York New York United States 10021
25 Mid-Carolina Cardiology Research Division/Presbyterian Hospital Charlotte North Carolina United States 28204
26 LeBauer Cardiovascular Research Foundation Greensboro North Carolina United States 27401
27 Forsyth Medical Center Winston-Salem North Carolina United States 27103
28 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
29 The Lindner Clinical Trial Center Cincinnati Ohio United States 45219
30 Cleveland Clinic Foundation Cleveland Ohio United States 44195
31 North Ohio Research, Ltd Elyria Ohio United States 44035
32 Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma United States 73120
33 St. Mary's Medical Center Langhorne Pennsylvania United States 19047
34 The Miriam Hospital Providence Rhode Island United States 02906
35 South Carolina Heart Center Columbia South Carolina United States 29204
36 St. Thomas Hospital Nashville Tennessee United States 37205
37 South Austin Hospital/Capital Cardiovascular Specialists Austin Texas United States 78745
38 The Methodist Hospital Research Institute in Cardiovascular Interventions Houston Texas United States 77030
39 University of Virginia Charlottesville Virginia United States 22908
40 Swedish Medical Center Seattle Washington United States 98104
41 Sunnybrook & Women's College Health Sciences Centre Toronto Ontario Canada M4N 3M5
42 Toronto General Hospital Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Principal Investigator: Gregg W. Stone, MD, Columbia University
  • Principal Investigator: Stephen G. Ellis, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00287573
Other Study ID Numbers:
  • S5442
  • TAXUS V ISR
First Posted:
Feb 7, 2006
Last Update Posted:
Aug 6, 2010
Last Verified:
Aug 1, 2010
Additional relevant MeSH terms:
Coronary Restenosis

Study Results

No Results Posted as of Aug 6, 2010