NCT01913600

Resolute Integrity US Extended Length Sub-Study(RI US XL)

Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.

Detailed description

The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System. Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Resolute Integrity Stent	Drug eluting stent (DES)

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-10-01
• Completion: 2018-12-01
• First posted: 2013-08-01
• Last updated: 2019-05-08
• Results posted: 2017-11-17

Locations

1 site across 1 country: United States