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

Sponsored by:	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 Device: TAXUS™ LIBERTÉ™ Paclitaxel Eluting Coronary Stent	Phase IV

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Paclitaxel Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

SPIRIT V Diabetic Study: in-stent Late Loss(LL) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
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 Diabetic Study: Acute Success (Clinical Device Success and Clinical Procedure Success) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: In-segment, proximal and distal Late Loss [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: In-stent and in-segment Angiographic Binary Restenosis rates [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: In-stent and in-segment percent Diameter Stenosis [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: Adjudicated Revascularizations (TLR/TVR/any Revascularization) both clinical-indicated and not clinical-indicated. [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: Adjudicated Composite rate of Cardiac Death, Myocardial Infarction (MI) attributed to the target vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
SPIRIT V Diabetic Study: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
SPIRIT V Registry: Acute Success (Clinical Device Success and 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, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 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, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR [ Time Frame: at 30 days, 240 days, 1, 2, 3, 4 and 5 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, 240 days, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3000
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2013
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator TAXUS™ Liberté™ Paclitaxel Eluting Coronary Stent System	Device: TAXUS™ LIBERTÉ™ Paclitaxel Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease.

Detailed Description:

The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Study and the Registry. The study will be conducted in up to 150 study centers outside the United States. Approximately 3,000 patients will be enrolled in the study.

The SPIRIT V Diabetic Study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V™ EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

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.

Eligibility

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

Criteria

Inclusion Criteria:

SPIRIT V Diabetic Study:

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
diagnosed with diabetes, as documented by medical history.
evidence of myocardial ischemia
acceptable candidate for CABG surgery
agree to undergo all CIP-required follow-up examinations
artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
maximum of one, de novo, target lesion per native major epicardial vessel or side branch
target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
target lesion ≤ 28 mm in length by visual estimate
target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1

SPIRIT V Registry:

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:

SPIRIT V Diabetic Study:

known diagnosis of AMI within 72 hours preceding the index procedure
current unstable arrhythmias
LVEF < 30%
received a heart or any other organ transplant or is on a waiting list for any organ transplant
receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
known hypersensitivity or contraindication to specific agents
elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
platelet count limits, WBC limits or documented or suspected liver disease
renal insufficiency
history of bleeding diathesis or coagulopathy or will refuse blood transfusions
CVA or TIA within the past 6 months
significant GI or urinary bleed within the past 6 months
other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.

Angiographic Exclusion Criteria of the Diabetic Study

target lesion meets specific criteria
target vessel 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. 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

SPIRIT V Registry:

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 104 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

Responsible Party:	Matt Kiely ( Abbott Vascular )
Study ID Numbers:	05-369
Study First Received:	November 17, 2006
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00402272
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

Study placed in the following topic categories:

Everolimus
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis

Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Paclitaxel
Coronary Artery Disease

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mitosis Modulators

Tubulin Modulators
Cardiovascular Diseases
Antimitotic Agents
Immunosuppressive Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009