Alpine vs. Xpedition: Evaluation of Stent Delivery System

Percutaneous Coronary Intervention Clinical Trial

— AXES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03451617
• Other study ID #: 201600966
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2017
• Last updated: February 23, 2018
• Start date: October 5, 2017
• Est. completion date: October 5, 2020

Study information

• Verified date: February 2018
• Source: University of Groningen
• Contact: Pim van der Harst, Prof. Dr.
• Phone: +31 50 3612355
• Email: p.van.der.harst[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Device:
• Stent delivery with Xpedition
Use of Xpedition stent delivery system to implant the XIENCE stent
• Stent delivery with Alpine
Use of Alpine stent delivery system to implant the XIENCE stent

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University of Groningen	Abbott

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crossing time	Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.	During PCI procedure
Secondary	Procedural time		During PCI procedure
Secondary	Total procedural costs	Total cost of the materials used during the procedure (stent delivery system and additional materials) in euros.	During PCI procedure
Secondary	Radiation dose		During PCI procedure
Secondary	Radiation time		During PCI procedure
Secondary	Contrast dose		During PCI procedure