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Alpine vs. Xpedition: Evaluation of Stent Delivery System (AXES)

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ClinicalTrials.gov Identifier: NCT03451617
Recruitment Status : Unknown
Verified February 2018 by Pim van der Harst, University of Groningen.
Recruitment status was:  Recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Pim van der Harst, University of Groningen

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

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Device: Stent delivery with Xpedition Device: Stent delivery with Alpine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : October 5, 2020
Arms and Interventions
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Arm Intervention/treatment
Xpedition stent delivery system Device: Stent delivery with Xpedition
Use of Xpedition stent delivery system to implant the XIENCE stent
Alpine stent delivery system Device: Stent delivery with Alpine
Use of Alpine stent delivery system to implant the XIENCE stent


Outcome Measures
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Primary Outcome Measures :
  1. Crossing time [ Time Frame: During PCI procedure ]
    Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.


Secondary Outcome Measures :
  1. Procedural time [ Time Frame: During PCI procedure ]
  2. Total procedural costs [ Time Frame: During PCI procedure ]
    Total cost of the materials used during the procedure (stent delivery system and additional materials) in euros.

  3. Radiation dose [ Time Frame: During PCI procedure ]
  4. Radiation time [ Time Frame: During PCI procedure ]
  5. Contrast dose [ Time Frame: During PCI procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451617


Contacts
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Contact: Pim van der Harst, Prof. Dr. +31 50 3612355 p.van.der.harst@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Pim van der Harst, Prof. Dr.       p.van.der.harst@umcg.nl   
Sponsors and Collaborators
University of Groningen
Abbott
More Information
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Responsible Party: Pim van der Harst, Prof. Dr. P. van der Harst, University of Groningen
ClinicalTrials.gov Identifier: NCT03451617    
Other Study ID Numbers: 201600966
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes