Alpine vs. Xpedition: Evaluation of Stent Delivery System

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

Detailed Description
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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).

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

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Stent delivery with Xpedition
* Device: Stent delivery with Alpine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Xpedition stent delivery system<br> | Device: Stent delivery with Xpedition<br>* Use of Xpedition stent delivery system to implant the XIENCE stent<br>|
| Other: Alpine stent delivery system<br> | Device: Stent delivery with Alpine<br>* Use of Alpine stent delivery system to implant the XIENCE stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crossing time | Proportion of procedures with crossing time (from introduction of guidewire to stent deployment) longer than 30 minutes. | During PCI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time |  | During PCI procedure | 
| Total procedural costs | Total cost of the materials used during the procedure (stent delivery system and additional materials) in euros. | During PCI procedure | 
| Radiation dose |  | During PCI procedure | 
| Radiation time |  | During PCI procedure | 
| Contrast dose |  | During PCI procedure |