---
title: Evaluation of WIRION™ EPS in Lower Extremities Arteries
nct_id: NCT02780349
overall_status: COMPLETED
phase: NA
sponsor: Gardia Medical
study_type: INTERVENTIONAL
primary_condition: Peripheral Arterial Disease (PAD)
countries: United States, Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02780349.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02780349"
ct_last_update_post_date: 2018-03-15
last_seen_at: "2026-05-12T07:30:33.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of WIRION™ EPS in Lower Extremities Arteries

**NCT ID:** [NCT02780349](https://clinicaltrials.gov/study/NCT02780349)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 103
- **Lead Sponsor:** Gardia Medical
- **Conditions:** Peripheral Arterial Disease (PAD)
- **Start Date:** 2016-05
- **Completion Date:** 2017-09-30
- **CT.gov Last Update:** 2018-03-15

## Brief Summary

Demonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)

## Eligibility

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

```
Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures
3. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations
4. Rutherford classification 2-4
5. Has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries
6. Planned atherectomy of the native femoropopliteal arteries
7. Reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm
8. An adequate "landing zone" for placement of the WIRION™ device distal to the target lesion of at least 30mm
9. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure
2. A lesion deemed not accessible by the WIRION™ EPS
3. Inability to take aspirin or ADP receptor antagonists
4. History of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary
5. Has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment
6. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded)
7. Life expectancy less than 12 months
8. Known severe renal insufficiency (eGFR \<30 ml/min/1.72m2).
9. ≤1-vessel tibial run-off status
```

## Arms

- **WIRION EPS** (EXPERIMENTAL) — Single arm study. All patients undergo procedure with the WIRION EPS

## Interventions

- **WIRION** (DEVICE) — Embolic Protection System

## Primary Outcomes

- **Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.** _(time frame: 30 days)_ — MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)

## Locations (10)

- Denver VA Medical Center, Denver, Colorado, United States
- Unity Point, Davenport, Iowa, United States
- Ochsner Clinic, New Orleans, Louisiana, United States
- St Elizabeth Medical Center, Boston, Massachusetts, United States
- St John Hospital, Detroit, Michigan, United States
- Columbia Presbyterian, New York, New York, United States
- Lankenau Institute for Medical Research, Philadelphia, Pennsylvania, United States
- Miriam Hospital, Providence, Rhode Island, United States
- Universitats herzzentrum Bad Krozingen, Bad Krozingen, Germany
- Universitatklinikum Leipzig, Leipzig, Germany

## Recent Field Changes (last 30 days)

- `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)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.denver va medical center|denver|colorado|united states` — added _(2026-05-12)_
- `locations.unity point|davenport|iowa|united states` — added _(2026-05-12)_
- `locations.ochsner clinic|new orleans|louisiana|united states` — added _(2026-05-12)_
- `locations.st elizabeth medical center|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.st john hospital|detroit|michigan|united states` — added _(2026-05-12)_
- `locations.columbia presbyterian|new york|new york|united states` — added _(2026-05-12)_
- `locations.lankenau institute for medical research|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.miriam hospital|providence|rhode island|united states` — added _(2026-05-12)_
- `locations.universitats herzzentrum bad krozingen|bad krozingen||germany` — added _(2026-05-12)_
- `locations.universitatklinikum leipzig|leipzig||germany` — added _(2026-05-12)_

---

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