Coronary Artery Disease Clinical Trial
Official title:
SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
This study is divided into 5 arms:
1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single
blind, parallel two-arm multi-center clinical trial in the United States (US) comparing
XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter
stents) to the Food and Drug Administration (FDA) approved commercially available
active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™
PECS) System
2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0
mm diameter stents) in Japan
The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston
Scientific.
The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the
XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS
(XIENCE V® arm) will be compared to an active control group represented by the FDA approved
commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent
(TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).
The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which
will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS®
EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within
vessel sizes >= 2.5 mm and <= 3.75 mm.
The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25
mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese
non-randomized arm as follows:
1. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel
sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently
in the US 2.25 mm non-randomized treatment arm
2. 80 subjects with a maximum of two de novo native coronary artery lesion within vessel
sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently
in the US 4.0 mm non-randomized treatment arm
3. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel
sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled
concurrently in the US 38 mm non-randomized treatment arm.
4. 88 Japanese subjects with a maximum of two de novo native coronary artery lesions
within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be
enrolled concurrently in the non-randomized Japanese arm.
All subjects in the RCT and the four non-randomized arms will be screened per the protocol
required inclusion/exclusion criteria. The data collected will be compared to data from the
subjects enrolled into the TAXUS® arm of US RCT.
Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an
angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:
Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up
at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)
All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected
through 270 days will be submitted as the primary data set for US and Japanese market
approval), and 1, 2, 3, 4, and 5 years (for annual reports).
All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0
mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270
days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects
enrolled in these arms.
All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical
follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.
All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup
(angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their
primary assignment at randomization. At sites without IVUS capability, subjects receiving
bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240
days after the index procedure). Angiographic follow-up is required for all bailout subjects
at 240 days.
Data from the US RCT will be submitted to the FDA as the primary data set for product
approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data
of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of
Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5
mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be
submitted to the FDA as additional safety data. Data from the US non-randomized arms of the
trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm
and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent
(RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the
US.
A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the
US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of
everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects
(minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion
treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion
treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK
measurements performed. These subsets will include subjects receiving overlapping stents.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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