NCT03451617

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

November 9, 2017

Last Update Submit

February 23, 2018

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Crossing time

    Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.

    During PCI procedure

Secondary Outcomes (5)

  • Procedural time

    During PCI procedure

  • Total procedural costs

    During PCI procedure

  • Radiation dose

    During PCI procedure

  • Radiation time

    During PCI procedure

  • Contrast dose

    During PCI procedure

Study Arms (2)

Xpedition stent delivery system

OTHER
Device: Stent delivery with Xpedition

Alpine stent delivery system

OTHER
Device: Stent delivery with Alpine

Interventions

Stent delivery with XpeditionDEVICE

Use of Xpedition stent delivery system to implant the XIENCE stent

Xpedition stent delivery system
Stent delivery with AlpineDEVICE

Use of Alpine stent delivery system to implant the XIENCE stent

Alpine stent delivery system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Central Study Contacts

Pim van der Harst, Prof. Dr.

CONTACT

+31 50 3612355p.van.der.harst@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. P. van der Harst

Study Record Dates

First Submitted

November 9, 2017

First Posted

March 2, 2018

Study Start

October 5, 2017

Primary Completion

October 5, 2019

Study Completion

October 5, 2020

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

NL(1)