NCT03218787

XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.

A Safety Evaluation of 3-month Dual Antiplatelet Therapy in Subjects at High Risk of Bleeding Undergoing Percutaneous Coronary Intervention With XIENCE.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,047 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents. The XIENCE family stent systems include commercially approved XIENCE Xpedition Everolimus Eluting Coronary Stent System (EECSS), XIENCE Alpine EECSS, XIENCE PRO\^X EECSS \[rebrand of the XIENCE Xpedition Stent System and is only available outside of the United States (OUS)\], XIENCE PRO\^A EECSS (rebrand of the XIENCE Alpine Stent System and is only available OUS) and XIENCE Sierra EECSS of coronary drug-eluting stents.

Detailed description

A. Primary Objective: To show non-inferiority of the primary endpoint of all death or all MI (modified ARC) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT compared to a historical control after propensity score adjustment. B. Secondary Objective: * To show superiority of the major secondary endpoint of major bleeding (Bleeding Academic Research Consortium \[BARC\] type 2-5) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT compared to a historical control after propensity score adjustment. * To evaluate stent thrombosis (ARC definite/probable) from 3 to 12 months following XIENCE implantation in HBR subjects treated with 3-month DAPT against a performance goal (PG). All registered subjects will be followed at 3, 6 and 12 months post index procedure. The data collected from this study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA study, which is a US post-approval study to evaluate the safety of XIENCE V EECSS in "all-comer" population under real-world setting.

Conditions

• Coronary Artery Lesions

Interventions

Type	Name	Description
DEVICE	XIENCE	Subjects who received XIENCE family stent systems will be included.
DRUG	DAPT	3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days. Subject who are "3-month clear" will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care.

Timeline

• Start date: 2017-07-19
• Primary completion: 2020-09-04
• Completion: 2020-09-04
• First posted: 2017-07-17
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

101 sites across 1 country: United States

Regulatory

• FDA-regulated device study