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

NCT07122518 | Not Yet Recruiting FDA Device

• 1 other identifier: P23-8501
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Artery Stenosis

Keywords

pulmonary artery stenosis; Pulmonary Artery Stenting; PALMAZ MULLINS XD Pulmonary Stent

Outcome Measures

Primary Outcomes (3)

• Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)

  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.

  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.

  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: 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

  Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure

Other Outcomes (10)

• Baseline Characteristics - Demographics

  Pre-procedure baseline

• Baseline Characteristics - Medical History

  Pre-procedure baseline

• Baseline Characteristics - Clinical History: Weight

  Pre-procedure baseline

Study Arms (1)

Palmaz Mullins XD™ Treatment

All enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent

Device: PALMAZ MULLINS XD™ Pulmonary Stent

Interventions

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.

Palmaz Mullins XD™ Treatment

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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 PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cordis US Corp.: lead
• Congenital Cardiovascular Interventional Study Consortium (CCISC): collaborator

MeSH Terms

Conditions

Stenosis, Pulmonary Artery

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jenny Jimenez

CONTACT

1 669-255-4123; jenny.jimenez@cordis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 14, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-07