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Cardiovascular DiseasesPhase 1NCT00497367

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

A Phase 1 study testing Percutaneous Coronary Intervention (PCI) TAXUS Petal in people with Cardiovascular Diseases, run by Boston Scientific Corporation at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Percutaneous Coronary Intervention (PCI) TAXUS Petal
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
4 sitesin 3 countries
Study dates
Jul 2007to Jun 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 65Show fewer
  • 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

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

New Zealand2 sites

  • Mercy Angiography Unit, 98 Mountain Road, First Floor

    Auckland, Epsom, 1003

  • Auckland City Hospital, Cardiac Investigations Unit, Park Road

    Auckland, Grafton, 1030

Other trials in New Zealand

France1 site

  • Institut Hospitalier Jacques Cartier-ICPS, 6, Avenue du Noyer Lambert

    Massy, 91349

Other trials in France

Germany1 site

  • HELIOS Klinikum Siegburg, Ringstrasse 49

    Siegburg, 53721

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
Percutaneous Coronary Intervention (PCI) TAXUS Petal
Keywords
safety, feasibility, bifurcation, lesion, de novo, intervention
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary Intervention (PCI) TAXUS PetalDevice

    TAXUS Petal, paclitaxel eluting stent

Study groups in NCT00497367
Study groupRoleWhat they receive
TAXUS® Petal™ Paclitaxel-Eluting Coronary StentExperimentalThis arm received the TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent.
Receives: Device: Percutaneous Coronary Intervention (PCI) TAXUS Petal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR

    Measured: 30 days

Secondary outcomes (1)

  1. 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

    Measured: Index procedure, 30 days, 6 months and 1 - 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2008
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00497367
Sponsor's protocol ID
S2030
Other IDs
S2030-FHU-2007
Status last verified
Mar 2015
First submitted
4 Jul 2007
Last updated
26 Mar 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 20542797

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Percutaneous Coronary Intervention (PCI) TAXUS Petal in people with Cardiovascular Diseases, run by Boston Scientific Corporation at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 65 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in New Zealand, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00497367, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.

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