SPIRIT XLV PAS Fact Sheet
Download the fact sheet for more information about SPIRIT XLV PAS.
SPIRIT XLV PAS will evaluate the continued safety and effectiveness of the 4.5 mm and 5.0 mm diameter XIENCE Skypoint™ Stent System used for the treatment of coronary artery disease (CAD).1 The device is implanted in large vessel arteries and provides support to prevent the vessel from reclosing. The stent releases a drug into the artery over the course of 4 months to promote healing and keep the artery open.2,3
SPIRIT XLV PAS is a prospective, single-arm study. This means that all patients will be receiving a 4.5 mm or 5.0 mm diameter XIENCE Skypoint™ Stent System.1
Participation in the study is over 3 years. Patients will have 5 study visits over that period, all of which can be conducted in person or over the telephone.
There will be at least 100 patients in SPIRIT XLV PAS at a global level.
If you have been diagnosed with CAD, you may be eligible to participate in SPIRIT XLV PAS. Talk to your doctor to see if SPIRIT XLV PAS is right for you.
Clinical studies are very important to advancing medicine and can help others lead healthier lives. Some people join a study because the treatments they have tried for their health problem did not work or because there is no treatment available. There is no guarantee or promise that you will receive any benefit from participating in the study. The information gathered in this study may add to the understanding of treatment options for patients with coronary artery disease.
There are multiple criteria that patients must meet to qualify for SPIRIT XLV PAS.1 For example:
Visit Is SPIRIT XLV PAS Right for Me? to learn more. You can also ask your doctor about your eligibility for this study and treatment options that are available to you.
Applies to XIENCE Skypoint™ Stent Systems:
Applies to XIENCE Sierra™ and XIENCE Alpine™ Stent Systems:
The XIENCE Skypoint™, XIENCE Sierra™ and XIENCE Alpine™ Stent Systems are contraindicated for use in:
Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
Potential Adverse Events
Adverse events that may be associated with PCI treatment procedures and the use of a stent in native coronary arteries include, but are not limited to, the following:
The risks described below include the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings and precaution sections of the everolimus labels / SmPCs and / or observed at incidences ≥ 10% in clinical trials with oral everolimus for different indications. Please refer to the drug SmPCs and labels for more detailed information and less frequent adverse events.
There may be other potential adverse events that are unforeseen at this time.