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

Boston Scientific

Status and phase

Completed

Phase 1

Conditions

Cardiovascular Diseases

Treatments

Device: Percutaneous Coronary Intervention (PCI) TAXUS Petal

Study type

Interventional

Funder types

Industry

Identifiers

NCT00497367

S2030

S2030-FHU-2007

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)