Exhale (R) Stent for Emphysema

Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic treatment that has the potential to reduce shortness of breath in emphysema patients. This study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.

Official Title

A Prospective Feasibility Study to Evaluate the Safety and Performance of the Exhale(R) Drug-Eluting Stent System in Patients With Emphysema

Conditions

Emphysema

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Procedural and technical success – operatively
• Decrease in residual volume > 300mL from baseline
• Safety

Secondary Outcome Measures:

• Dyspnea scoring
• Pulmonary function measures
• Exercise tolerance
• Quality of life measures

Study Start

July 2004; Study completion: May 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 80 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• High resolution computed tomography (CT) scan evidence of bilateral emphysema
• Residual volume (RV) >= 220% predicted.
• Total lung capacity (TLC) >= 133% of predicted value.
• Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 litre.
• Marked dyspnea, scoring >= 2 on the modified Medical Research Council scale of 0-4.
• Patient has undergone pulmonary rehabilitation of 16 – 20 sessions.

Exclusion Criteria:

• FEV1 > 20%
• Diffusing capacity for carbon monoxide (DLco) < 15% of predicted.
• Respiratory infection requiring > 3 hospitalizations in past year
• Inability to walk > 140 meters in 6 minutes
• Giant bulla > 1/3 of one lung’s volume
• Previous lung volume reduction surgery (LVRS) or lobectomy.

Total Enrolment

60

Contact Details

• Concord Repatriation General Hospital, Burwood, 2134, Australia
• The Prince Charles Hospital, Rode Road, Chermside, Queensland, 4032, Australia
• The Alfred Hospital, Prahran, Victoria, 3181, Australia

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