NCT03451617

Alpine vs. Xpedition: Evaluation of Stent Delivery System

Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent.

Detailed description

Rationale: The current gold standard for percutaneous coronary intervention (PCI) is the second generation drug-eluting stent (DES). The most commonly used DES is the everolimus-eluting stent (EES). New stent delivery systems for PCI with EES are developed to optimize strength, flexibility and pushability of the catheter. The effect on procedural time of new stent delivery systems has not yet been investigated in clinical practice. Objective: To evaluate and compare the performance of two stent delivery systems for PCI with EES. Study design: Randomized comparative trial with 500 patients in the University Medical Center Groningen (UMCG). Study population: All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility. Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained. Intervention: The first group will undergo PCI with the XIENCE EES using the Alpine stent delivery system, the second group will undergo PCI with the Xpedition stent delivery system. Main study parameters/endpoints: The primary endpoint is the proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes. Secondary endpoints include procedural time (from heparin administration to removal of catheter sheath, mins), use of additional materials, total procedural costs, radiation dose (μGym2), radiation time (mins), and contrast dose (ml).

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Stent delivery with Xpedition	Use of Xpedition stent delivery system to implant the XIENCE stent
DEVICE	Stent delivery with Alpine	Use of Alpine stent delivery system to implant the XIENCE stent

Timeline

• Start date: 2017-10-05
• Primary completion: 2019-10-05
• Completion: 2020-10-05
• First posted: 2018-03-02
• Last updated: 2018-03-02

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study