Alpine vs. Xpedition: Evaluation of Stent Delivery System
NCT ID: NCT03451617
Last Updated: 2018-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2017-10-05
2020-10-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Xpedition stent delivery system
Stent delivery with Xpedition
Use of Xpedition stent delivery system to implant the XIENCE stent
Alpine stent delivery system
Stent delivery with Alpine
Use of Alpine stent delivery system to implant the XIENCE stent
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to obtain (verbal) informed consent
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
University of Groningen
OTHER
Responsible Party
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Pim van der Harst
Prof. Dr. P. van der Harst
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201600966
Identifier Type: -
Identifier Source: org_study_id
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