Clinical trial NCT00287573: Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Official title: A Prospective, Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Restenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-02-07
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Target Vessel Revascularization
timeFrame: 9 Months
Secondary outcomes:
measure: Incidence of composite major adverse cardiac events (MACE) and the individual components of MACE
timeFrame: assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years
measure: Stent thrombosis rate
timeFrame: 5 Years
measure: 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).
timeFrame: 5 Years
measure: Clinical procedural success and technical success
timeFrame: 5 Years
measure: Binary restenosis rate
timeFrame: 5 years
measure: Evaluate outcomes and treatment of recurrent restenosis in the TAXUS stent arm
timeFrame: 5 Years
measure: Absolute lesion length
timeFrame: 9 Months
measure: Reference Vessel Diameter (RVD)
timeFrame: 9 Months
measure: Minimum Lumen Diameter (MLD)
timeFrame: 9 Months
measure: Percent diameter stenosis (% DS)
timeFrame: 9 Months
measure: Acute gain
timeFrame: 9 Months
measure: Late loss
timeFrame: 9 Months
measure: Loss index
timeFrame: 9 Months
measure: Patterns of recurrent restenosis, including edge effect
timeFrame: 9 Months
measure: Coronary aneurysm
timeFrame: 9 Months
measure: Identification of potential safety issues.
timeFrame: 9 Months
measure: Change in neointimal volume from post procedure to follow-up
timeFrame: 9 Months
measure: Change in MLD within the stent or area of brachytherapy
timeFrame: 9 Months
measure: Minimum lumen area (MLA) within the stent or area of brachytherapy
timeFrame: 9 Months
measure: Lumen, plaque and vessel measurements at the treatment edges (outside of the stent or area of brachytherapy)
timeFrame: 9 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: LaJolla
country: United States
facility: Scripps Green Hospital
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Stanford
country: United States
facility: Stanford Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Northern Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Albany
country: United States
facility: Albany Medical Center/Capital Cardiovascular Associates
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology Research Division/Presbyterian Hospital
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Elyria
country: United States
facility: North Ohio Research, Ltd
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Langhorne
country: United States
facility: St. Mary's Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: South Austin Hospital/Capital Cardiovascular Specialists
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute in Cardiovascular Interventions
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Columbia University
name: Gregg W. Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Stephen G. Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.