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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00497367




Registration number
NCT00497367
Ethics application status
Date submitted
4/07/2007
Date registered
6/07/2007
Date last updated
26/03/2015

Titles & IDs
Public title
Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System
Scientific 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
Secondary ID [1] 0 0
S2030-FHU-2007
Secondary ID [2] 0 0
S2030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Percutaneous Coronary Intervention (PCI) TAXUS Petal

Experimental: TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent - This arm received the TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent.


Treatment: Devices: Percutaneous Coronary Intervention (PCI) TAXUS Petal
TAXUS Petal, paclitaxel eluting stent
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Index procedure, 30 days, 6 months and 1 - 5 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Massy
Country [2] 0 0
Germany
State/province [2] 0 0
Siegburg
Country [3] 0 0
New Zealand
State/province [3] 0 0
Epsom
Country [4] 0 0
New Zealand
State/province [4] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Ormiston, MD
Address 0 0
Auckland City Hospital, Grafton, Auckland NZ
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00497367