Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07122518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
Sponsor:
Cordis US Corp.
Organization:
Study Overview
Official Title:
A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REALPASS
Brief Summary:
The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.
Detailed Description:
The clinical study is a prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent. The study will enroll a minimum of 35 subjects and a maximum of 75 subjects in up to 11 U.S sites or until the end of the 2-year enrollment period has been reached, whichever comes first.
The study will collect the performance and safety data of the PALMAZ MULLINS XD™ Pulmonary Stent through time of hospital discharge.
The study will collect the performance and safety data of the PALMAZ MULLINS XD™ Pulmonary Stent through time of hospital discharge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: