XIENCE V: SPIRIT WOMEN

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00496938
First received: July 3, 2007
Last updated: September 26, 2011
Last verified: September 2011

July 3, 2007
September 26, 2011
July 2007
August 2010   (final data collection date for primary outcome measure)
Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) [ Time Frame: at 1 year ]
Complete list of historical versions of study NCT00496938 on ClinicalTrials.gov Archive Site
  • Acute Success (Clinical Device Success and Clinical Procedure Success) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ 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 30 days ] [ 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 all Revascularization (TLR/TVR/non TVR. [ 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 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 1 Year ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 2 Years ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 2 years ] [ 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 Cardiac Death, MI attributed to the target vessel and CI-TLR. [ Time Frame: at 2 Years ] [ 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 Target Vessel Revascularization (TVR). [ 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 2 Years ] [ 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 Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [ Time Frame: at 2 years ] [ 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 ]
  • Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). [ Time Frame: at 2 Years ] [ Designated as safety issue: Yes ]
  • Acute Success (Clinical Device Success and Clinical Procedure Success) [ Time Frame: Acute ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 30 days, 240 days and at 1, 2, 3, 4 and 5 years ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 30 days, 240 days and at 1, 2, 3, 4 and 5 years ]
  • Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR . [ Time Frame: at 30 days, 240 days and at 1, 2, 3, 4 and 5 years ]
  • Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR) . [ Time Frame: at 30 days, 240 days and at 2, 3, 4 and 5 years ]
  • Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [ Time Frame: at 30 days, 240 days and at 1, 2, 3, 4 and 5 years ]
  • 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, 240 days and at 1, 2, 3, 4 and 5 years ]
  • In-stent Late Loss (LL)(main secondary endpoint for the randomized sub-study) [ Time Frame: at 270 days ]
  • In-segment Late Loss (LL) (for the randomized sub-study) [ Time Frame: at 270 days ]
  • In-stent and in-segment Angiographic Binary Restenosis rates(for the randomized sub-study) [ Time Frame: at 270 days ]
  • In-stent and in-segment percent Diameter Stenosis(for the randomized sub-study) [ Time Frame: at 270 days ]
  • Aneurysm, thrombus and persisting dissection(for the randomized sub-study) [ Time Frame: at 270 days ]
Not Provided
Not Provided
 
XIENCE V: SPIRIT WOMEN
A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

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.

SPIRIT Women Single-Arm Study: A prospective, open label, single arm, multi-center study evaluating performance of the XIENCE V® and XIENCE PRIME™ EECSS in the treatment of female patients with coronary artery lesions, per its Instructions for Use (IFU).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
1
Observational cohort using an all-comers design
Intervention: Device: XIENCE V®/ XIENCE PRIME™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1600
July 2011
August 2010   (final data collection date for primary outcome measure)

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 CIP-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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   China,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Latvia,   Malaysia,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   South Africa,   Spain,   Switzerland,   United Kingdom,   Venezuela
 
NCT00496938
07-377
Yes
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Marie-Claude Morice Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Principal Investigator: Stephan Windecker University Hospital Bern, Bern, Switzerland
Abbott Vascular
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP