Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency

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Brief Title

Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency

Official Title

Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients

Brief Summary

      The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung
      Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused
      emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction
      profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating
      improvement in lung function, exercise capacity, and quality of life relative to their
      baseline status.
    



Study Type

Interventional


Primary Outcome

symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit

Secondary Outcome

 Percent change in FEV1 from Baseline (Pre-Treatment Visit)

Condition

Alpha-1-Antitrypsin Deficiency

Intervention

Lung Volume Reduction Coil (PneumrX Inc.)

Study Arms / Comparison Groups

 Treatment
Description:  Patients with Alpha-1-Antitrypsin deficiency treated with endoscopic lung volume reduction using Lung Volume Reduction Coils (PneumRx Inc.)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

October 2014

Completion Date

October 2015

Primary Completion Date

August 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Patient > 18 years of age, diagnosed with AATD emphysema

          2. CT scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with
             sufficient lung parenchyma for coil deployment, in accordance with manufacturer
             recommendations (see section 5.2.4.1).

          3. Patient has post- bronchodilator FEV1 less than or equal to 45% predicted

          4. Total Lung Capacity > 100%

          5. Residual Volume (RV) >175% predicted

          6. Patient has stopped smoking for a minimum of 8 weeks prior to entering the study

          7. Patient has read, understood and signed the Informed Consent form

          8. Patient is willing and able to attend all required follow-up visits

          9. Patient is willing and able to undergo bilateral LVRC treatment

         10. Patient has received Pneumococcal and Influenza vaccinations consistent with local
             recommendations and/or policy

        Exclusion Criteria:

          1. Patient has a change in FEV1 > 20% post-bronchodilator.

          2. Patients DLCO < 20% predicted

          3. Patient has a history of recurrent clinically significant respiratory infection

          4. Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure
             >50mmHg and or evidenced by echocardiogram

          5. Patient has an inability to walk >140 meters (150 yards) in 6 minutes

          6. Patient has evidence of other disease that may compromise survival such as lung
             cancer, renal failure, etc.

          7. Patient is pregnant or lactating

          8. Patient has an inability to tolerate bronchoscopy under moderate sedation or
             anesthesia

          9. Patient has clinically significant bronchiectasis

         10. Patient has giant bullae > 1/3 lung volume

         11. Patient has had previous LVR surgery, lung transplant or lobectomy

         12. Patient has been involved in other pulmonary drug or device studies with 30 days prior
             to this study

         13. Patient is taking > 20mg prednisone (or similar steroid) daily

         14. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as
             heparin or coumadin) or has not been weaned off prior to procedure

         15. Patient has other condition that would interfere with completion of study, follow up
             assessments or that would adversely affect outcomes

         16. Patient has severe homogeneous emphysema by CT scan.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT02273349

Organization ID

PL001-AATD


Responsible Party

Sponsor

Study Sponsor

University Hospital, Saarland


Study Sponsor

, , 


Verification Date

May 2017