News | July 19, 2007

Abbott Enrolls First Patient in Study on DES Treatment in Women

July 19, 2007 – Abbott announced that the first patient was enrolled in its XIENCE V SPIRIT WOMEN clinical trial, the first clinical trial designed to study the safety and effectiveness of drug eluting stent treatment in women.
The goal of the XIENCE V SPIRIT WOMEN trial is to increase understanding of how heart disease affects women and to assess the performance of the XIENCE V Everolimus Eluting Coronary Stent System in women with previously untreated coronary artery lesions from Europe, Asia-Pacific, Canada and Latin America. The trial will focus on specific aspects of women’s health in relation to coronary artery disease such as general awareness about the disease, symptoms at time of presentation, referral patterns, and hormonal menopausal status. Liliana Grinfeld, M.D., of the Hospital Italiano in Buenos Aires, Argentina, performed the first procedure.
The XIENCE V SPIRIT WOMEN clinical trial is the first large interventional study to examine how cardiovascular disease differs in women from men. XIENCE V SPIRIT WOMEN will include approximately 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. The trial will evaluate patient and disease characteristics specific to women such as menopausal status and hormonal profiles, as well as treatment outcomes including death, heart attack, the need for re-treatment (target vessel revascularization or TVR) and potential risk of stent thrombosis. In a sub-set of about 450 patients, the trial will compare outcomes in patients treated with the XIENCE V Everolimus Eluting Coronary Stent System from Abbott with the CYPHER SELECT Plus Sirolimus-eluting Coronary Stent from Johnson & Johnson.
“We are honored to have enrolled the first patient in the important XIENCE V SPIRIT WOMEN trial because it is designed to address issues associated with the under-treatment of women with cardiovascular disease,” said Dr. Grinfeld. “The XIENCE V Everolimus Eluting Coronary Stent System performed well, and as with all patients enrolled in the XIENCE V SPIRIT WOMEN trial, the patient will be followed out to 5 years.”

For more information:

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Biosensors, BioFreedom drug-coated stent, LEADERS FREE II IDE trial, first patient, U.S. pivotal study
News | Stents Drug Eluting| March 03, 2017
Biosensors International Group Ltd. announced in February enrollment of the first patient in LEADERS FREE II, its new...
CeloNova Cobra Pzf stent
Technology | Stents| March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Overlay Init