Health TrialsbyHealthPanel

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

ConditionPulmonary Artery Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCordis US Corp.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Palmaz Mullins XD™ Treatment1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure
2

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.

Time frame
Index procedure (start time to end time)
3

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 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

Secondary outcomes

Other outcomes

1

Baseline Characteristics - Demographics

Demographics (age, gender)

Time frame
Pre-procedure baseline
2

Baseline Characteristics - Medical History

Medical History (diagnosis, prior surgery)

Time frame
Pre-procedure baseline
3

Baseline Characteristics - Clinical History: Weight

Clinical History (weight in kg)

Time frame
Pre-procedure baseline
4

Baseline Characteristics - Clinical History: Height

Clinical History (height in cm)

Time frame
Pre-procedure baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cordis US Corp.

Lead sponsor

Congenital Cardiovascular Interventional Study Consortium (CCISC)

Collaborator

Source ClinicalTrials.gov
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