A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and preliminary performance of the ROX Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.

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Detailed Description

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Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations to the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX percutaneous Anastomotic Coupler System.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Anastomotic Coupler System + standard of care per GOLD

Group Type EXPERIMENTAL

ROX Anastomotic Coupler System (ACS)

Intervention Type DEVICE

The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)

Group B

Standard of care per GOLD alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ROX Anastomotic Coupler System (ACS)

The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.

Exclusion Criteria

* Subjects not meeting Stage III or IV Chronic Obstructive Pulmonary Disease (COPD)
* Subjects with significant comorbidities
* Subjects not qualifying because of physical or psychological condition that may put them at risk of participating

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No