---
title: "Alpine vs. Xpedition: Evaluation of Stent Delivery System"
nct_id: NCT03451617
overall_status: UNKNOWN
phase: NA
sponsor: University of Groningen
study_type: INTERVENTIONAL
primary_condition: Percutaneous Coronary Intervention
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03451617.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03451617"
ct_last_update_post_date: 2018-03-02
last_seen_at: "2026-05-12T06:50:10.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Alpine vs. Xpedition: Evaluation of Stent Delivery System

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

**NCT ID:** [NCT03451617](https://clinicaltrials.gov/study/NCT03451617)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** University of Groningen
- **Collaborators:** Abbott
- **Conditions:** Percutaneous Coronary Intervention
- **Start Date:** 2017-10-05
- **Completion Date:** 2020-10-05
- **CT.gov Last Update:** 2018-03-02

## Brief Summary

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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Xpedition stent delivery system** (OTHER)
- **Alpine stent delivery system** (OTHER)

## Interventions

- **Stent delivery with Xpedition** (DEVICE) — Use of Xpedition stent delivery system to implant the XIENCE stent
- **Stent delivery with Alpine** (DEVICE) — Use of Alpine stent delivery system to implant the XIENCE stent

## Primary Outcomes

- **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 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)_

## Locations (1)

- University Medical Center Groningen, Groningen, Netherlands — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university medical center groningen|groningen||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03451617.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03451617*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*