IN.PACT™ AV Access Post-Approval Study (PAS002)
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|ClinicalTrials.gov Identifier: NCT04543539|
Recruitment Status : Not yet recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment|
|Arteriovenous Fistula Arteriovenous Fistula Stenosis Arteriovenous Fistula Occlusion Fistula||Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||240 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||IN.PACT™ AV Access Post-Approval Study (PAS002)|
|Estimated Study Start Date :||October 17, 2020|
|Estimated Primary Completion Date :||October 17, 2025|
|Estimated Study Completion Date :||October 17, 2027|
IN.PACT™ AV Access PAS Primary Cohort
The primary cohort consists of enrolled subjects treated with the IN.PACT™ AV DCB according to labeling requirements who meet the inclusion/exclusion criteria for the primary cohort.
Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
IN.PACT™ AV Access PAS Extended Cohort
The extended cohort consists of enrolled subjects who do not meet the eligibility criteria for the primary cohort and receive the IN.PACT™ AV DCB device for treatment of stenosis in the AV circuit.
Combination Product: IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit
- Infection and Infestations Serious Adverse Events [ Time Frame: Through 12 months post-index procedure ]Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.
- Mortality Rate [ Time Frame: Through 1, 2, 3, 4, and 5 years post-index procedure ]Determine mortality rate
- Extended Cohort - Characterize Infections and Infestations Serious Adverse Events [ Time Frame: Through 1-year and all-cause mortality through 5-years post-index procedure ]Characterize infections and infestations Serious Adverse Events, including pneumonia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543539
|Contact: PSR Study Teamfirstname.lastname@example.org|