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

Coronary Restenosis Clinical Trial

— TAXUS V ISR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287573
• Other study ID #: S5442
• Secondary ID: TAXUS V ISR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 3, 2006
• Last updated: August 5, 2010
• Start date: June 2003
• Est. completion date: January 2010

Study information

• Verified date: August 2010
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: January 2010
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• TAXUS Express2
Paclitaxel-Eluting Coronary Stent System

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

Locations

Country	Name	City	State
Canada	Sunnybrook & Women's College Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Albany Medical Center/Capital Cardiovascular Associates	Albany	New York
United States	Piedmont Hospital	Atlanta	Georgia
United States	Aurora Denver Cardiology	Aurora	Colorado
United States	South Austin Hospital/Capital Cardiovascular Specialists	Austin	Texas
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Buffalo General Hospital	Buffalo	New York
United States	Lahey Clinic Hospital	Burlington	Massachusetts
United States	Mid-Carolina Cardiology Research Division/Presbyterian Hospital	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	South Carolina Heart Center	Columbia	South Carolina
United States	North Ohio Research, Ltd	Elyria	Ohio
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	The Methodist Hospital Research Institute in Cardiovascular Interventions	Houston	Texas
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Scripps Green Hospital	LaJolla	California
United States	St. Mary's Medical Center	Langhorne	Pennsylvania
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	St. Thomas Hospital	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	Maine Medical Center	Portland	Maine
United States	The Miriam Hospital	Providence	Rhode Island
United States	Mercy General Hospital	Sacramento	California
United States	Swedish Medical Center	Seattle	Washington
United States	Barnes Jewish Hospital	St. Louis	Missouri
United States	Stanford Medical Center	Stanford	California
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Target Vessel Revascularization		9 Months	Yes
Secondary	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	Yes
Secondary	Stent thrombosis rate		5 Years	Yes
Secondary	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	Yes
Secondary	Clinical procedural success and technical success		5 Years	Yes
Secondary	Binary restenosis rate		5 years	Yes
Secondary	Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm		5 Years	Yes
Secondary	Absolute lesion length		9 Months	No
Secondary	Reference Vessel Diameter (RVD)		9 Months	No
Secondary	Minimum Lumen Diameter (MLD)		9 Months	No
Secondary	Percent diameter stenosis (% DS)		9 Months	Yes
Secondary	Acute gain		9 Months	Yes
Secondary	Late loss		9 Months	No
Secondary	Loss index		9 Months	No
Secondary	Patterns of recurrent restenosis, including edge effect		9 Months	Yes
Secondary	Coronary aneurysm		9 Months	Yes
Secondary	Identification of potential safety issues.		9 Months	Yes
Secondary	Change in neointimal volume from post procedure to follow-up		9 Months	Yes
Secondary	Change in MLD within the stent or area of brachytherapy		9 Months	Yes
Secondary	Minimum lumen area (MLA) within the stent or area of brachytherapy		9 Months	Yes
Secondary	Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)		9 Months	Yes