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| Name | Class |
|---|---|
| Congenital Cardiovascular Interventional Study Consortium (CCISC) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palmaz Mullins XD™ Treatment | All enrolled subjects are treated with the PALMAZ MULLINS XD™ Pulmonary Stent |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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:
| Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics - Demographics | Demographics (age, gender) | Pre-procedure baseline |
| Baseline Characteristics - Medical History | Medical History (diagnosis, prior surgery) |
- 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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Jimenez | Contact | 1 669-255-4123 | jenny.jimenez@cordis.com |
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| ID | Term |
|---|---|
| D000071079 | Stenosis, Pulmonary Artery |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Pre-procedure baseline |
| Baseline Characteristics - Clinical History: Weight | Clinical History (weight in kg) | Pre-procedure baseline |
| Baseline Characteristics - Clinical History: Height | Clinical History (height in cm) | Pre-procedure baseline |
| Baseline Characteristics - Clinical History: Body Surface Area | Clinical History (body surface area in square meters) | Pre-procedure baseline |
| Target Vessel Characteristics (Stenosis type and location, lesion length and target vessel diameters) | Stenosis type and location, lesion length and target vessel diameters | Angiography during index procedure |
| Procedural Characteristics (occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure) | Occurrence and outcomes of pre-dilation, stent deployment and post-dilation during index procedure | Index procedure |
| Device Characteristics - Dimensions of PALMAZ MULLINS XD™ Pulmonary Stent | PALMAZ MULLINS XD™ Pulmonary Stent dimensions | Index procedure |
| Device Characteristics - Balloon Manufacturer/Model and Dimensions | Balloon manufacturer/model and dimensions | Index procedure |
| Device Characteristics - Sheath Manufacturer/Model and Dimensions | Sheath manufacturer/model and dimensions | Index procedure |