SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Phase 3

Completed

• Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis
• Interventions: Device: XIENCE V® Everolimus Eluting Coronary Stent; Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

• Registration Number: NCT00180310
• Lead Sponsor: Abbott Medical Devices

Brief Summary

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System.

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Detailed Description

The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-16
• Primary Completion: 2007-07
• Study Completion: 2011-02
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate
• The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a TIMI flow of >= 1
• Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure or if planned to be done > 9 months after the index procedure

Exclusion Criteria

• De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure
• Target lesion(s) restenotic from previous intervention
• Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy
• Target vessel(s) contains visible thrombus
• Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
• Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	XIENCE V® Everolimus Eluting Coronary Stent	XIENCE V® Everolimus Eluting Coronary Stent System
2	TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent	TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Primary Outcome Measures

Name	Time	Method
In-stent late loss (LL)	at 180 days

Secondary Outcome Measures

Name	Time	Method
In-segment Late Loss	at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent Late Loss at 2 years (for a subset of 152 patients)	at 2 years (for a subset of 152 patients)
Proximal and distal Late Loss	at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate	at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent and in-segment percent Diameter Stenosis (% DS)	at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent percent Volume Obstruction (% VO)	at 180 days and at 2 years for a subset of 152 patients
Plaque behind the stent( by IVUS)	at 180 days and at 2 years for a subset of 152 patients
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate	at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Ischemia Driven Target Vessel Failure (ID-TVF)	at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)	at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Persisting incomplete stent apposition, late-acquired incomplete stent apposition	at 180 days and at 2 years for a subset of 152 patients
Aneurysm, thrombosis and persisting dissection	at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Acute success(device, procedure and clinical)	Acute

Trial Locations

Locations (32)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

C.H.U. de Liège Sart Tilman; 🇧🇪 Liège, Belgium

A.Z. Middelheim; 🇧🇪 Antwerpen, Belgium

Århus University Hospital; 🇩🇰 Aarhus, Denmark

C.H.R. La Citadelle; 🇧🇪 Liège, Belgium

Aalborg Sygehus Syd; 🇩🇰 Aalborg, Denmark

Hôpital de Rangueil CHU; 🇫🇷 Toulouse, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

Hôpital Cochin; 🇫🇷 Paris, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Amper Kliniken AG Klinikum Dachau; 🇩🇪 Dachau, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Clinique Saint Gatien; 🇫🇷 Tours, France

Klinikum Kassel; 🇩🇪 Kassel, Germany

Herzzentrum Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

Herz- und Gefäßzentrum Hamburg; 🇩🇪 Hamburg, Germany

Max Devki Devi Heart & Vascular Institute; 🇮🇳 New Delhi, India

Amphia Hospital; 🇳🇱 Breda, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

St. Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Azienda Ospedaliera Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

The Mercy Hospital; 🇳🇿 Auckland, Epsom, New Zealand

Isala Klinieken - Locatie Weezenlanden; 🇳🇱 Zwolle, Netherlands

Vergelegen Mediclinic; 🇿🇦 Cape Town, South Africa

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Auckland City Hospital; 🇳🇿 Auckland, Grafton, New Zealand

National Institute of Cardiology in Warsaw; 🇵🇱 Warsaw, Poland

Kantonsspital Basel; 🇨🇭 Basel, Switzerland

University Hospital Gregorio Maranon; 🇪🇸 Madrid, Spain

R.V. Hôpital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

Wilheminenspital der Stadt Wien; 🇦🇹 Vienna, Austria