A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions

NCT00297804 | Completed Phase 2 DMC

• 2 other identifiers: S2009TAXUS VI
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate rate-release formulation of triblock copolymer carrier system in patients with a higher risk of target lesion revascularisation and restenosis.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Percutaneous Coronary Intervention; Stent Implant; Drug-coated Stent

Outcome Measures

Primary Outcomes (1)

• Rate of TVR 9 months after index procedure

  9 Months

Secondary Outcomes (7)

• • Rates of composite Major Adverse Cardiac Events (MACE) and the individual components of MACE, assessed at 1, 3, 6 and 9 months after the study procedure and annually for 5 years (i.e., 1, 2, 3, 4, and 5 years after the study procedure).

  5 years

• Stent thrombosis rate.

  5 Years

• Target Vessel Failure.

  5 years

• Clinical procedural success.

  Post procedure

• Binary restenosis rate.

  9 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Device: TAXUS Express Paclitaxel-Eluting Coronary Stent System

Arm 2

ACTIVE COMPARATOR

Device: Control stent

Interventions

TAXUS Express Paclitaxel-Eluting Coronary Stent System DEVICE

Paclitaxel-Eluting Coronary Stent System

Arm 1

Control stent DEVICE

control stent

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient \>or= 18 years old
• Eligible for percutaneous coronary intervention
• Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
• Acceptable candidate for CABG
• Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
• Willing to comply with all specified follow-up evaluations
• Target lesion located within a single native coronary vessel
• Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by up to 2 study stents (maximum allowable stent length of 48 mm).
• Cumulative target lesion length is \>or= 18 mm and \<or= 40 mm (visual estimate)
• RVD of \>or= 2.5 mm to \<or= 3.75 mm (visual estimate)
• Target lesion diameter stenosis \>or=50% (visual estimate)
• Target lesion is de novo

You may not qualify if:

• Known sensitivity to paclitaxel
• Any previous or planned treatment with any anti-restenotic drug-coated or drug-eluting coronary stent (Note: previous or planned treatment with heparin or phosphorylcholine coated stents is acceptable, as long as the procedure with the stent meets the protocol defined criteria for staged procedures)
• Previous or planned treatment with intravascular brachytherapy in the target vessel
• MI within 72 hours prior to the study procedure and/or CK-MB \>2x the local laboratory's upper limits of normal (refers to a measured value on the day of the study procedure)
• Left ventricular ejection fraction \<25%
• Cerebrovascular Accident within the past 6 months
• Acute or chronic renal dysfunction (creatinine \>1.7 mg/dl or \>150 µmol/L)
• Contraindication to ASA, or to both clopidogrel and ticlopidine
• Leukopenia (leukocyte count \<3.5 x 109/liter)
• Thrombocytopenia (platelet count \<100,000/mm3)
• Active peptic ulcer or active gastrointestinal bleeding
• Known allergy to stainless steel
• Any prior true anaphylactic reaction to contrast agents
• Known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the study procedure
• Patient is currently taking colchicine

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

HELIOS Clinic

Siegburg, 53721, Germany

Location

Related Publications (1)

• 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.

  PMID: 22496083 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eberhard Grube, MD

  HELIOS Clinic Siegburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2006
• First Posted: March 1, 2006
• Study Start: May 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: February 1, 2008
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)