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
  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™
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1600
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Observational cohort using an all-comers design
Device: XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

Detailed Description:

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.

  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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496938

  Show 95 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: NCT00496938     History of Changes
Other Study ID Numbers: 07-377
Study First Received: July 3, 2007
Last Updated: September 26, 2011
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
Atherosclerosis
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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 20, 2014