XIENCE Skypoint Large Vessel Post Approval Study
Conditions: Coronary Artery Disease
Sponsor: Abbott Medical Devices

 
 
NCT Number: NCT05423379 
SPIRIT XLV PAS 
XIENCE Skypoint Large Vessel Post Approval Study 
(SPIRIT XLV PAS) 
Study Document No: ABT-CIP-10445 
Version B 
Date: 13-JUN-2023 
 
 
Sponsor 
Abbott 
3200 Lakeside Drive 
Santa Clara, CA 95054 
United States of America 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express written 
consent of Abbott. 
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a Abbott
Study Name: SPIRIT XLV PAS 
1.0 
INTRODUCTION 
The XIENCE Skypoint Large Vessel Post-Approval Study (PAS) (called "SPIRIT XLV PAS" hereafter) is 
a prospective, single-arm, open-label, multi-center global (United States [US] and outside of US [OUS]) 
clinical study to evaluate the continued safety and effectiveness of the XI ENCE Skypoint Large Vessel 
(LV) sizes (stent diameters 4.5 mm and 5.0 mm in stent lengths of 12-33 mm) everolimus-eluting
M(EECSS) after the US market approval, in a minimum of
N with a minimum of 
.
This clinical study 
will be conducted in accordance with this clinical investigation plan (CIP). All investigators involved in the 
clinical study will be qualified by education, training, or experience to perform their tasks and this training 
will be documented appropriately. 
1.1 
Background and Rationale 
1.1.1 
Background 
A post-approval study to evaluate the continued safety and effectiveness of the XI ENCE Skypoint stent 
diameters 4.5 and 5.0 mm was required by FDA, which is planned to be conducted following the clinical 
investigation plan (CIP) described in this document. 
i -XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME): P110019, approved 11/1/11 
-XIENCE Xpedition Everolimus Eluting Coronary Stent System (XI ENCE Xpedition): P110019 / S025, approved 12/21/12
-XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine): P110019 / S070, approved 9/3/14
-XIENCE Sierra Everolimus Eluting Coronary Stent System (XIENCE Sierra): P110019 / S094 approved 5/22/18
-XIENCE Skypoint Everolimus Eluting Coronary Stent System (XIENCE Skypoint): P110019 / S113 approved 5/13/21
ii - MUL Tl-LINK VISION® (VISION): P020047, approved 7/16/ 3 - MULTI-LINK MINI-VISION® (MINI-VISION):
P020047/S003, approved 9/10/04 
- Multi-Link 8® and Multi-Link 8® Long Lesion Coronary Stent System (ML8): P020047/S017, approved 6/22/10
- Multi-Link 8® Small Vessel Corona 
Stent S stem ML8 : P020047/S022, a 
roved 8/31/10
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