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

NCT00497367 | Completed Phase 1

• 2 other identifiers: S2030S2030-FHU-2007
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 4

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

Conditions

Cardiovascular Diseases

Keywords

safety; feasibility; bifurcation; lesion; de novo; intervention

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (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

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

Study Arms (1)

TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent

EXPERIMENTAL

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

Device: Percutaneous Coronary Intervention (PCI) TAXUS Petal

Interventions

Percutaneous Coronary Intervention (PCI) TAXUS Petal DEVICE

TAXUS Petal, paclitaxel eluting stent

TAXUS® Petal™ Paclitaxel-Eluting Coronary Stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

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

Massy, 91349, France

Location

HELIOS Klinikum Siegburg, Ringstrasse 49

Siegburg, 53721, Germany

Location

Mercy Angiography Unit, 98 Mountain Road, First Floor

Auckland, Epsom, 1003, New Zealand

Location

Auckland City Hospital, Cardiac Investigations Unit, Park Road

Auckland, Grafton, 1030, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 20542797 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• John Ormiston, MD

  Auckland City Hospital, Grafton, Auckland NZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: June 1, 2013
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

DE (1); NZ (2); FR (1)