Percutaneous Coronary InterventionAXESNCT03451617
Alpine vs. Xpedition: Evaluation of Stent Delivery System
A study testing Stent delivery with Xpedition and Stent delivery with Alpine in people with Percutaneous Coronary Intervention, run by University of Groningen at 1 site in Netherlands.
Trial summary
To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Stent delivery with Xpedition and Stent delivery with Alpine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Oct 2017to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing PCI with EES, aged 18 years or older
Who cannot join
- Chronic total occlusion (CTO) PCI
- Inability to obtain (verbal) informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700 RB
Pim van der Harst, Prof. Dr., p.van.der.harst@umcg.nl
About this study
Official title: Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent
To evaluate and compare the performance of two stent delivery systems for percutaneous coronary intervention with everolimus-eluting stent.
Read the 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).
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Stent delivery with Xpedition, Stent delivery with Alpine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent delivery with XpeditionDevice
Use of Xpedition stent delivery system to implant the XIENCE stent
Stent delivery with AlpineDevice
Use of Alpine stent delivery system to implant the XIENCE stent
| Study group | Role | What they receive |
|---|---|---|
| Xpedition stent delivery system | Other | Not described Receives: Device: Stent delivery with Xpedition |
| Alpine stent delivery system | Other | Not described Receives: Device: Stent delivery with Alpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossing time
Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.
Measured: During PCI procedure
Secondary outcomes (5)
Procedural time
Measured: During PCI procedure
Total procedural costs
Total cost of the materials used during the procedure (stent delivery system and additional materials) in euros.
Measured: During PCI procedure
Radiation dose
Measured: During PCI procedure
Radiation time
Measured: During PCI procedure
Contrast dose
Measured: During PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start5 Oct 2017
- Primary completion5 Oct 2019 (estimated)
- Study completion5 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Pim van der Harst, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451617
- Sponsor's protocol ID
- 201600966
- Acronym
- AXES
- Status last verified
- Feb 2018
- First submitted
- 9 Nov 2017
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Evaluation of Alpine® vs. Xpedition® Stent Delivery System of the XIENCE® Everolimus-eluting Stent
- ClinicalTrials.gov ID
- NCT03451617
- Acronym / sponsor ID
- AXES / 201600966
- Conditions
- Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 5 Oct 2019 (estimated)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xpedition stent delivery system | Other | Device: Stent delivery with Xpedition |
| Alpine stent delivery system | Other | Device: Stent delivery with Alpine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing PCI with EES, aged 18 years or older
Key exclusion criteria (2 listed)
- Chronic total occlusion (CTO) PCI
- Inability to obtain (verbal) informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent delivery with XpeditionUse of Xpedition stent delivery system to implant the XIENCE stent | Device | Xpedition stent delivery system |
| Stent delivery with AlpineUse of Alpine stent delivery system to implant the XIENCE stent | Device | Alpine stent delivery system |
Primary outcome
Crossing time
Time frame: During PCI procedure
Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes.
5 secondary outcomes
Procedural time
Time frame: During PCI procedure
Total procedural costs
Time frame: During PCI procedure
Radiation dose
Time frame: During PCI procedure
Radiation time
Time frame: During PCI procedure
Contrast dose
Time frame: During PCI procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent delivery with Xpedition and Stent delivery with Alpine in people with Percutaneous Coronary Intervention, run by University of Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pim van der Harst, Prof. Dr. (+31 50 3612355, p.van.der.harst@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crossing time (time frame: During PCI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.