Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07122518

Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pulmonary Artery Stenosis Arterial Occlusive Diseases Cardiovascular Diseases Stenosis, Pulmonary Artery Vascular Diseases

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Subjects *should* meet criteria as per the list of indications/contraindications in the Instructions for Use, though all subjects treated with PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.

Treatment and study plan

PALMAZ MULLINS XD™ Pulmonary Stent

Device

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.

Primary outcomes

  1. 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

    • 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.

  2. 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.

  3. 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:

    • 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

Other outcomes

  1. Baseline Characteristics - Demographics

    Time frame: Pre-procedure baseline

    Demographics (age, gender)

  2. Baseline Characteristics - Medical History

    Time frame: Pre-procedure baseline

    Medical History (diagnosis, prior surgery)

  3. Baseline Characteristics - Clinical History: Weight

    Time frame: Pre-procedure baseline

    Clinical History (weight in kg)

  4. Baseline Characteristics - Clinical History: Height

    Time frame: Pre-procedure baseline

    Clinical History (height in cm)

  5. Baseline Characteristics - Clinical History: Body Surface Area

    Time frame: Pre-procedure baseline

    Clinical History (body surface area in square meters)

  6. Target Vessel Characteristics (Stenosis type and location, lesion length and target vessel diameters)

    Time frame: Angiography during index procedure

    Stenosis type and location, lesion length and target vessel diameters

  7. Procedural Characteristics (occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure)

    Time frame: Index procedure

    Occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure

  8. Device Characteristics - Dimensions of PALMAZ MULLINS XD™ Pulmonary Stent

    Time frame: Index procedure

    PALMAZ MULLINS XD™ Pulmonary Stent dimensions

  9. Device Characteristics - Balloon Manufacturer/Model and Dimensions

    Time frame: Index procedure

    Balloon manufacturer/model and dimensions

  10. Device Characteristics - Sheath Manufacturer/Model and Dimensions

    Time frame: Index procedure

    Sheath manufacturer/model and dimensions

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Jimenez

CONTACT

[email protected]

1 669-255-4123

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Collaborators

  • Congenital Cardiovascular Interventional Study Consortium (CCISC)

Registry information

Official study title

A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)

Acronym: REALPASS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.