Pulmonary Artery StenosisREALPASSNCT07122518
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
An observational study of Pulmonary Artery Stenosis, run by Cordis US Corp. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Artery Stenosis
- What is being tested?
- PALMAZ MULLINS XD™ Pulmonary Stent
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with pulmonary artery stenosis who are candidates for treatment with the PALMAZ MULLINS XD™ Pulmonary Stent according to clinical guidelines and/or the operators' judgement will be eligible for enrollment in this study.
- Subjects *should* meet criteria as per the list of indications/contraindications in the Instructions for Use, though all subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rajesh Nathan contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Jimmy Kuo, MD
Jimmy Kuo, MD
- Recruiting
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Shabana Shahanavaz, MD
Shabana Shahanavaz, MD
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Neha Ahluwalia, MD
Neha Ahluwalia, MD
- Not yet recruiting
Texas Children's Hospital
Houston, Texas, 77030
Asra Khan, MD
Asra Khan
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Jeffrey Delaney, MD
Jeffrey Delaney, MD
- Not yet recruiting
UMPC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Bryan Goldstein, MD
Bryan Goldstein, MD
- Not yet recruiting
UC Davis Children's Hospital
Sacramento, California, 95817
Frank Ing, MD
Frank Ing, MD
- Not yet recruiting
St Louis Children's Hospital
St Louis, Missouri, 63110
Dominic Zanaboni, MD
Dominic Zanaboni, MD
About this study
Official title: A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
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.
Read the 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.
- Conditions
- Pulmonary Artery Stenosis
- Being tested
- PALMAZ MULLINS XD™ Pulmonary Stent
- Keywords
- pulmonary artery stenosis, Pulmonary Artery Stenting, PALMAZ MULLINS XD Pulmonary Stent
- Medical subject headings
- Stenosis, Pulmonary Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PALMAZ MULLINS XD™ Pulmonary StentDevice
The PALMAZ MULLINS XD™ Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy. The PALMAZ MULLINS XD™ Pulmonary Stent is a balloon-expandable, laser cut stent made from 316L stainless steel tubing. The stent is supplied unmounted and in five (5) nominal unexpanded lengths: 19 mm, 25 mm, 29 mm, 39 mm, and 59 mm.
| Study group | Role | What they receive |
|---|---|---|
| Palmaz Mullins XD™ Treatment | All enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent Receives: Device: PALMAZ MULLINS XD™ Pulmonary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
- Successful access, delivery and retrieval of the device delivery system,
- Deployment and correct positioning of the device in the intended location, and
- No need for additional, unplanned surgery or re-intervention related to the device or access procedure.
Measured: Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)
Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.
Measured: Index procedure (start time to end time)
Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)
Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria:
- Led to a death,
- Led to a serious deterioration in health of the subject, that either resulted in
- Life-threatening illness or injury, or
- Hospitalization (initial or prolonged) or
- Disability or permanent impairment of a body structure or a body function or
- Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
- Other Serious (important) Medical Events
Measured: Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start23 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congenital Cardiovascular Interventional Study Consortium (CCISC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122518
- Sponsor's protocol ID
- P23-8501
- Acronym
- REALPASS
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
- ClinicalTrials.gov ID
- NCT07122518
- Acronym / sponsor ID
- REALPASS / P23-8501
- Conditions
- Pulmonary Artery Stenosis
- Keywords
- pulmonary artery stenosis, Pulmonary Artery Stenting, PALMAZ MULLINS XD Pulmonary Stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- Congenital Cardiovascular Interventional Study Consortium (CCISC)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palmaz Mullins XD™ Treatment | – | Device: PALMAZ MULLINS XD™ Pulmonary StentAll enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with pulmonary artery stenosis who are candidates for treatment with the PALMAZ MULLINS XD™ Pulmonary Stent according to clinical guidelines and/or the operators' judgement will be eligible for enrollment in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PALMAZ MULLINS XD™ Pulmonary StentThe PALMAZ MULLINS XD™ Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy. The PALMAZ MULLINS XD™ Pulmonary Stent is a balloon-expandable, laser cut stent made from 316L stainless steel tubing. The stent is supplied unmounted and in five (5) nominal unexpanded lengths: 19 mm, 25 mm, 29 mm, 39 mm, and 59 mm. | Device | Palmaz Mullins XD™ Treatment |
Primary outcome
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
Time frame: Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure
1. Successful access, delivery and retrieval of the device delivery system, 2. Deployment and correct positioning of the device in the intended location, and 3. No need for additional, unplanned surgery or re-intervention related to the device or access procedure.
Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)
Time frame: Index procedure (start time to end time)
Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.
Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)
Time frame: Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria: 1. Led to a death, 2. Led to a serious deterioration in health of the subject, that either resulted in 1. Life-threatening illness or injury, or 2. Hospitalization (initial or prolonged) or 3. Disability or permanent impairment of a body structure or a body function or 4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. Other Serious (important) Medical Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Nathan contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Stenosis, run by Cordis US Corp. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Jimenez (1 669-255-4123, jenny.jimenez@cordis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention) (time frame: Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.