Recruiting

PALMAZ MULLINS XD™

Sponsor:

Cordis US Corp.

Code:

NCT07122518

Conditions

Pulmonary Artery Stenosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PALMAZ MULLINS XD™ Pulmonary Stent

Study Details

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

Study ID

NCT07122518

Start date

Jun 23, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

\- 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.

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Palmaz Mullins XD™ Treatment

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

Interventions

PALMAZ MULLINS XD™ Pulmonary Stent

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 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 ]
  • 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) ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jenny Jimenez

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

Rajesh Nathan

rajesh.nathan@cordis.com

Locations

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Neha Ahluwalia, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

Principal Investigator:

Jeffrey Delaney, MD

Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Principal Investigator:

Shabana Shahanavaz, MD

More Information

Sponsor

Cordis US Corp.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Cordis US Corp. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.