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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01182428
Other study ID # 07-377 sub-study
Secondary ID
Status Completed
Phase Phase 4
First received July 13, 2010
Last updated July 23, 2012
Start date September 2008
Est. completion date July 2011

Study information

Verified date July 2012
Source Abbott Vascular
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 455
Est. completion date July 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Argentina Hosital Italiano de Buenos Aires - Cardiologia Buenos Aires
Argentina Instituto Cardiovascular de Buenos Aires-ICBA Buenos Aires
Austria Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II Wien
Belgium Heilig Hart Ziekenhuis Roeselare Roeselare
Brazil Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia Sao Paulo
Denmark Rigshospitalet Copenhagen
France Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud Massy
Germany Kardiologische Klinik Herz- und Diabeteszentrum Bad Oeynhausen
Germany Segebergerkliniken Bad Segeberg
Germany Technische Universität Dresden, Medizinische Klinik II - Kardiologie Dresden
Hungary Semmelweis University, Department of Cardiovascular Surgery Budapest
Italy Centro Cardiologico Monzino Milan
Italy Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO Milano
Italy Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena Modena
Italy Ospedale Cisanello Pisa
Italy Istituto Clinico Humanitas Rozzano
Latvia Latvian Center of Cardiology, P. Stradina University Hospital Riga
Netherlands AMC Amsterdam
Netherlands St. Antonius Ziekenhuis Nieuwegein
Norway Haukeland university hospital Bergen
Poland Institute of Cardiology Warsaw
Spain Hospital General de Alicante Alicante
Spain Hospital Universitari Germans Trias i Pujol Barcelona
Switzerland Inselspital Bern, Kardiologie Bern
Switzerland Cardiocentro Ticino Lugano

Sponsors (1)

Lead Sponsor Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Denmark,  France,  Germany,  Hungary,  Italy,  Latvia,  Netherlands,  Norway,  Poland,  Spain,  Switzerland, 

References & Publications (1)

Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond Engl). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). 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. at 1 year Yes
Primary In-stent Late Loss (LL) (Main Secondary Endpoint) In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up. at 270 days Yes
Secondary Clinical Device Success Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system. Intra-operative Yes
Secondary Clinical Procedure Success 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. Intra-operative Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable) < 1 day (Acute) Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable) 1 to 30 days (Sub-Acute) Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable) 30 days to 1 year (Late) Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable, Possible) 30 days to 1 year (Late) Yes
Secondary Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). at 30 days Yes
Secondary Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. at 240 days Yes
Secondary Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. at 1 year Yes
Secondary Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). at 30 days Yes
Secondary Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). at 240 days Yes
Secondary Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). at 30 days Yes
Secondary Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). at 240 days Yes
Secondary Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). at 1 year Yes
Secondary Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). at 30 days Yes
Secondary Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). at 240 days Yes
Secondary Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). at 1 year Yes
Secondary In-segment Late Loss (LL) LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up at 270 days Yes
Secondary In-stent Angiographic Binary Restenosis Rates 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). at 270 days Yes
Secondary In-segment Angiographic Binary Restenosis Rates 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). at 270 days Yes
Secondary In-stent Percent Diameter Stenosis at 270 days Yes
Secondary In-segment Percent Diameter Stenosis at 270 days Yes
Secondary Adjudicated Revascularization (TLR/TVR/All Revascularizations) Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations at 30 days Yes
Secondary Adjudicated Revascularization (TLR/TVR/All Revascularizations) Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations at 240 days Yes
Secondary Adjudicated Revascularization (TLR/TVR/All Revascularizations) Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations at 1 year Yes
Secondary Aneurysm All subjects with aneurysm of the target lesion up to the 270 day follow-up visit at 270 days Yes
Secondary Thrombus All subjects with thrombus of the target lesion up to the 270 day follow-up visit at 270 days Yes
Secondary Persisting Dissection All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit at 270 days Yes
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