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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
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
Trial website
https://clinicaltrials.gov/study/NCT00497367
Trial related presentations / publications
Ormiston JA, Lefevre T, Grube E, Allocco DJ, Dawkins KD. First human use of the TAXUS Petal paclitaxel-eluting bifurcation stent. EuroIntervention. 2010 May;6(1):46-53.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00497367