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

Sponsor:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00402272

Purpose

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.

Condition	Intervention	Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis	Device: XIENCE V® Everolimus Eluting Coronary Stent	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	2700
Study Start Date:	November 2006
Study Completion Date:	June 2010
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 XIENCE V® Everolimus Eluting Coronary Stent System	Device: XIENCE V® Everolimus Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease. Other Name: XIENCE V® Everolimus Eluting Coronary Stent System

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402272

Show 93 Study Locations

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:	Eberhard Grube, MD	The Heart Center, Siegburg, Germany
Principal Investigator:	Upendra Kaul, MD	Fortis Hospital, New Delhi, India

More Information

No publications provided

Responsible Party:	Ellen Travis, Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00402272 History of Changes
Other Study ID Numbers:	05-369
Study First Received:	November 17, 2006
Last Updated:	October 13, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott Vascular:

drug eluting stents
stents
Angioplasty
coronary artery disease
total coronary occlusion

coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Everolimus

Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 13, 2012