XIENCE V: SPIRIT WOMEN Sub-study - Full Text View

Purpose

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

Condition	Intervention	Phase
Coronary Artery Stenosis Coronary Arteriosclerosis Coronary Artery Disease Coronary Artery Restenosis Total Coronary Occlusion Stent Thrombosis Vascular Disease Myocardial Ischemia	Device: XIENCE V®/ XIENCE PRIME™ Device: CYPHER SELECT	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Vascular Diseases

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.
In-stent Late Loss (LL) (Main Secondary Endpoint) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.

Secondary Outcome Measures:

Clinical Device Success [ Time Frame: Intra-operative ] [ Designated as safety issue: Yes ]
Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
Clinical Procedure Success [ Time Frame: Intra-operative ] [ Designated as safety issue: Yes ]
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.
Adjudicated Stent Thrombosis (Definite, Probable) [ Time Frame: < 1 day (Acute) ] [ Designated as safety issue: Yes ]
Adjudicated Stent Thrombosis (Definite, Probable) [ Time Frame: 1 to 30 days (Sub-Acute) ] [ Designated as safety issue: Yes ]
Adjudicated Stent Thrombosis (Definite, Probable) [ Time Frame: 30 days to 1 year (Late) ] [ Designated as safety issue: Yes ]
Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: 30 days to 1 year (Late) ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
In-segment Late Loss (LL) [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
In-stent Angiographic Binary Restenosis Rates [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
In-segment Angiographic Binary Restenosis Rates [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).
In-stent Percent Diameter Stenosis [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
In-segment Percent Diameter Stenosis [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
Adjudicated Revascularization (TLR/TVR/All Revascularizations) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Adjudicated Revascularization (TLR/TVR/All Revascularizations) [ Time Frame: at 240 days ] [ Designated as safety issue: Yes ]
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Adjudicated Revascularization (TLR/TVR/All Revascularizations) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Aneurysm [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
Thrombus [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
All subjects with thrombus of the target lesion up to the 270 day follow-up visit
Persisting Dissection [ Time Frame: at 270 days ] [ Designated as safety issue: Yes ]
All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit

Enrollment:	455
Study Start Date:	September 2008
Study Completion Date:	July 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: XIENCE V® / XIENCE PRIME™	Device: XIENCE V®/ XIENCE PRIME™ Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Active Comparator: CYPHER SELECT	Device: CYPHER SELECT XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions

Detailed Description:

SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.

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 Women study after 2 years.

Eligibility

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

Criteria

General Inclusion Criteria:

Patient must be female.
Patient must be at least 18 years of age.
Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or 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.
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Patient must agree to undergo all protocol-required follow-up examinations.
Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic Inclusion Criteria:

Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
Target lesion greater than or equal to 28 mm in length by visual estimate.

General Exclusion Criteria:

Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182428

Show 25 Study Locations

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:	Marie-Claude Morice	Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Principal Investigator:	Stephan Windecker	University Hospital Bern, Bern, Switzerland

More Information

No publications provided

Responsible Party:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT01182428 History of Changes
Other Study ID Numbers:	07-377 sub-study
Study First Received:	July 13, 2010
Results First Received:	May 3, 2012
Last Updated:	July 23, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Abbott Vascular:

Stents
Angioplasty
Total coronary occlusions

Coronary restenosis
Stent thrombosis
Everolimus

Additional relevant MeSH terms:

Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

Embolism and Thrombosis
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 October 17, 2012