SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe

Phase 4

Completed

• Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

• Registration Number: NCT00402272
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

Detailed Description

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.

The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-22
• Primary Completion: 2008-02
• Study Completion: 2010-06
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-13
• Last Update Posted: 2010-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

• at least 18 years
• able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
• evidence of myocardial ischemia
• acceptable candidate for coronary artery bypass graft (CABG) surgery
• undergo all CIP-required follow-up examinations
• artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
• target lesions must be de novo lesions
• target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
• target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria

Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .	at 30 days

Secondary Outcome Measures

Name	Time	Method
SPIRIT V Registry: Acute Success (Clinical Procedure Success)	Acute
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)	at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)	at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR	at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR	at 30 days, 1 and 2 years
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)	at 30 days, 1 and 2 years
SPIRIT V Registry: Acute Success (Clinical Device Success)	Acute

Trial Locations

Locations (93)

Salzburger Landeskliniken; 🇦🇹 Salzburg, Austria

UCL St Luc; 🇧🇪 Brussels, Belgium

ULB Erasmus Hospital; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium

Hopital St Joseph; 🇧🇪 Gilly, Belgium

Clinique St. Luc - Bouge; 🇧🇪 Namur, Belgium

Foothills Medical Center; 🇨🇦 Calgary, Canada

CHUM Hotel Dieu Hospital; 🇨🇦 Montreal, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Canada

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