Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Boston Scientific Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00497367
First received: July 4, 2007
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an investigational device with an indication of improving coronary artery luminal diameter while maintaining side branch access in subjects with symptomatic ischemic disease due to discrete atherosclerotic bifurcation lesions


Condition Intervention Phase
Cardiovascular Diseases
Device: Percutaneous Coronary Intervention (PCI) TAXUS Petal
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective, Single-arm, Multicenter 2-phase Feasibility Study to Assess the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System (TAXUS Petal)for the Treatment of de Novo Atherosclerotic Bifurcation Lesions

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device Success Technical Success Clinical Procedural Success Device malfunctions Ease-of-Use parameters Clinical endpoints Main branch and side branch angiographic endpoints Main branch and side branch IVUS endpoints [ Time Frame: Index procedure, 30 days, 6 months and 1 - 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: July 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Percutaneous Coronary Intervention (PCI) TAXUS Petal
    TAXUS Petal, paclitaxel eluting stent
Detailed Description:

To assess the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System (TAXUS® Petal™) for the treatment of de novo atherosclerotic bifurcation lesions (by visual estimate):

  • Phase 1:

    • Main branch: 3.0 to 3.5 mm RVD and lesion length ≤20 mm
    • Side branch: 2.5 to 3.5 mm RVD and lesion length ≤14 mm
  • Phase 2:

    • Main branch: 3.0 to 3.5 mm RVD and lesion length ≤28 mm
    • Side branch: 2.25 to 3.5 mm RVD and lesion length ≤14 mm

Bifurcation main branch (MB) lesion length will be measured from the proximal shoulder of the most proximal lesion to the distal shoulder of the most distal lesion. Bifurcation side branch (SB) lesion length will be measured from the proximal shoulder of the side branch (if the ostium is disease-free) or the side branch ostium (if the disease continues into the main branch) to the distal side branch shoulder of the most distal lesion. At follow-up, the entire stented region will be used to determine MLD and %DS.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria - Phases 1 and 2

  • Age is ≥18 years old and ≤80 years old
  • Eligible for PCI
  • Acceptable candidate for CABG
  • Documented stable angina pectoris (CCS Classification 1, 2, 3, or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  • LVEF known to be ≥40%
  • Clinical angiographic success in non-target lesion (if a non-target lesion is treated)
  • Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
  • Subject willing to comply with follow-up evaluations

Exclusion Criteria - Phases 1 and 2

  • Contraindication to ASA, or to Thienopyridine derivatives (e.g. Clopidogrel, Ticlopidine)
  • High risk of bleeding
  • Known hypersensitivity to paclitaxel
  • Known allergy to stainless steel
  • Known allergy to platinum
  • Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
  • Previous treatment of the target vessel with BMS within 9 months before index procedure
  • Previous treatment of any non-target vessel with any anti-restenotic drug-coated or DES within 9 months before index procedure
  • Previous treatment with intravascular brachytherapy in the target vessel
  • Planned PCI or CABG post-index procedure
  • Planned target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter
  • Documented MI within 72 hours prior to index procedure
  • CK > 2 x ULN + positive CK-MB OR
  • CK > 2 x ULN + positive troponin OR
  • If no CK-MB or troponin was drawn, patients are excluded with CK > 2xULN
  • As per protocol definitions found in Appendix A:
  • CVA within the past 6 months
  • Cardiogenic shock
  • Acute or chronic renal dysfunction
  • Prior anaphylactic reaction to contrast agents
  • Leukopenia
  • Thrombocytopenia
  • Thrombocytosis
  • Active peptic ulcer or active GI bleeding
  • Current treatment, or past-treatment within 12 months of the index procedure, with paclitaxel or other chemotherapeutic agents
  • Anticipated treatment with paclitaxel or oral rapamycin within 9 months of index procedure
  • Subject's (men and women) known intention to procreate within 9 months of index procedure
  • Positive pregnancy test or nursing an infant within 7 days prior to index procedure
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid condition(s) that could limit subject's ability to comply with study follow-up or impact study scientific integrity
  • Currently participating in another investigational drug or device clinical study
  • Planned surgery at time of enrollment within the next 9 months after index procedure

Angiographic Inclusion Criteria - Phases 1 & 2

  • Target Lesion (main and / or side branch):
  • located in native coronary artery
  • must be de novo
  • main branch %DS is ≥50% and <100%
  • is a bifurcation lesion with an angle ≥30º and ≤90º
  • is enrolled after successful pre-dilatation of the target vessel

Angiographic Inclusion Criteria - Phase 1

  • Main branch of target lesion located in parent branch of LAD or LCx or RCA
  • Target lesion located in proximal or mid-section of vessel only (crux of RCA [distal RCA] is allowed)
  • Main branch RVD ≥3.00 mm to ≤3.5 mm; lesion length ≤20 mm (to be covered by TAXUS® Petal™ stent and maximum of 1 additional TAXUS stent ≤12 mm in length)
  • Side branch RVD ≥2.5 mm to ≤3.5 mm; lesion length ≤14 mm to be treated by maximum of 1 TAXUS stent ≤16 mm in length Angiographic Inclusion Criteria - Phase 2
  • Main branch of target lesion located in parent branch of LAD or LCx or RCA without restrictions
  • Main branch RVD ≥3.00 mm to ≤3.5 mm; lesion length ≤28 mm (to be covered by TAXUS® Petal™ stent and maximum of 1 additional TAXUS stent ≤20 mm in length)
  • Side branch RVD ≥2.25 mm to ≤3.5 mm; lesion length ≤14 mm to be treated by maximum of 1 TAXUS stent ≤16 mm in length

Angiographic Exclusion Criteria - Phases 1 & 2

  • Target lesion located in left main (protected or unprotected)
  • Medina Classification 0.0.1
  • Target lesion is restenotic
  • Target lesion located in a SVG or mammary artery graft
  • Target lesion accessed via SVG or mammary artery graft
  • Target lesion is <5 mm from BMS
  • Target lesion is <5 mm from second side branch vessel ≥1.5 mm in diameter
  • Untreated lesions with ≥50% DS or thought to impair flow remaining in target vessel
  • Target lesion and/or vessel proximal to target lesion moderately or severely calcified
  • Target lesion and/or target vessel proximal to target lesion severely tortuous
  • Main branch target lesion located within or distal to a >60° bend in target vessel
  • Target vessel with angiographic presence of probable or definite thrombus
  • Unprotected LM disease
  • Protected LM disease with target lesion in LAD or LCx (subject may be enrolled if only lesion is target lesion in RCA)

Angiographic Exclusion Criteria

  • Phase 1: Target lesion TIMI flow <3
  • Phase 2: Target lesion TIMI flow <2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497367

Locations
France
Institut Hospitalier Jacques Cartier-ICPS, 6, Avenue du Noyer Lambert
Massy, France, 91349
Germany
HELIOS Klinikum Siegburg, Ringstrasse 49
Siegburg, Germany, 53721
New Zealand
Mercy Angiography Unit, 98 Mountain Road, First Floor
Auckland, Epsom, New Zealand, 1003
Auckland City Hospital, Cardiac Investigations Unit, Park Road
Auckland, Grafton, New Zealand, 1030
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: John Ormiston, MD Auckland City Hospital, Grafton, Auckland NZ
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00497367     History of Changes
Other Study ID Numbers: S2030, S2030-FHU-2007
Study First Received: July 4, 2007
Last Updated: February 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Health and Disability Ethics Committees

Keywords provided by Boston Scientific Corporation:
safety
feasibility
bifurcation
lesion
de novo
intervention

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014