Alpine vs. Xpedition: Evaluation of Stent Delivery System

Not Applicable

• Conditions: Percutaneous Coronary Intervention
• Interventions: Device: Stent delivery with Xpedition; Device: Stent delivery with Alpine

• Registration Number: NCT03451617
• Lead Sponsor: University of Groningen

Brief 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).

Study Timeline

• Study Start: 2017-10-05
• Study First Submitted: 2017-11-09
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-23
• Last Update Submitted: 2018-02-23
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02
• Primary Completion: 2019-10-05
• Study Completion: 2020-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients undergoing PCI with EES, aged 18 years or older

Exclusion Criteria

• Chronic total occlusion (CTO) PCI
• Inability to obtain (verbal) informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xpedition stent delivery system	Stent delivery with Xpedition	-
Alpine stent delivery system	Stent delivery with Alpine	-

Primary Outcome Measures

Name	Time	Method
Crossing time	During PCI procedure	Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.

Secondary Outcome Measures

Name	Time	Method
Procedural time	During PCI procedure
Total procedural costs	During PCI procedure	Total cost of the materials used during the procedure (stent delivery system and additional materials) in euros.
Radiation dose	During PCI procedure
Radiation time	During PCI procedure
Contrast dose	During PCI procedure

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands