Pulmonary Artery Stenosis
Conditions
Keywords
pulmonary artery stenosis, Pulmonary Artery Stenting, PALMAZ MULLINS XD Pulmonary Stent
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.
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.
Interventions
DEVICEPALMAZ 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.
Sponsors
Congenital Cardiovascular Interventional Study Consortium (CCISC)
Cordis US Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention) | 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) | 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline Characteristics - Clinical History: Height | Pre-procedure baseline | Clinical History (height in cm) |
| Baseline Characteristics - Clinical History: Body Surface Area | Pre-procedure baseline | Clinical History (body surface area in square meters) |
| Target Vessel Characteristics (Stenosis type and location, lesion length and target vessel diameters) | Angiography during index procedure | Stenosis type and location, lesion length and target vessel diameters |
| Baseline Characteristics - Demographics | Pre-procedure baseline | Demographics (age, gender) |
| Device Characteristics - Dimensions of PALMAZ MULLINS XD™ Pulmonary Stent | Index procedure | PALMAZ MULLINS XD™ Pulmonary Stent dimensions |
| Device Characteristics - Balloon Manufacturer/Model and Dimensions | Index procedure | Balloon manufacturer/model and dimensions |
| Device Characteristics - Sheath Manufacturer/Model and Dimensions | Index procedure | Sheath manufacturer/model and dimensions |
| Procedural Characteristics (occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure) | Index procedure | Occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure |
| Baseline Characteristics - Medical History | Pre-procedure baseline | Medical History (diagnosis, prior surgery) |
| Baseline Characteristics - Clinical History: Weight | Pre-procedure baseline | Clinical History (weight in kg) |
Contacts
Primary ContactJenny Jimenez
Outcome results
None listed