Multicenter Early Feasibility Trial Studying the Renata Minima Stent

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Brief Title

Multicenter Early Feasibility Trial Studying the Renata Minima Stent

Official Title

Multicenter Early Feasibility Trial of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent

Brief Summary

      The objective of the clinical investigation is to access device performance and the initial
      clinical safety and effectiveness of the Minima Stent in neonates, infants, and young
      children requiring intervention for common congenital vascular stenosis (i.e., coarctation of
      the aorta and/or pulmonary artery stenosis) who are indicated for treatment.
    



Study Type

Interventional


Primary Outcome

Deployment

Secondary Outcome

 Arterial to arterial peak-to-peak pressure gradient to < 20 mmHg

Condition

Coarctation of the Aorta

Intervention

Catheterized Stenting


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

December 2021

Completion Date

June 2027

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          -  The subject's legally authorized representative has been informed of the nature of
             the- clinical investigation, agrees to its provisions, and has provided written
             informed consent

          -  Requiring treatment of:

               -  native or recurrent aortic coarctation, and/or

               -  native or recurrent pulmonary artery stenosis

               -  Vascular stenosis measuring < or equal to 50% of normal adjacent vessel

          -  Patency of at least one femoral vein, femoral artery, jugular vein or both carotid
             arteries able to accommodate the delivery system

          -  Adjacent vessel to stenosis measuring > or equal to 4 mm

        Exclusion Criteria:

          -  Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent
             implantation

          -  History of or active endocarditis (active treatment with antibiotics) within 180 days
             prior to stent implantation

          -  Aortic or pulmonary artery aneurysm in close proximity to the target lesion

          -  Body weight of < 1.5 kg

          -  Anatomic location of lesion judged by the investigator to not lend to the safe
             placement of a stent

          -  Target vessels larger or smaller than the Minima System balloon size ranges

          -  Currently participating in an investigational drug study or another device study

          -  Major or progressive non-cardiac disease resulting in a life expectancy of less than
             six months

          -  Known hypersensitivity to aspirin or heparin and cannot be treated with other
             antiplatelet and/or antithrombotic medications

          -  Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately
             pre-medicated
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, 8015569954, [email protected]



Administrative Informations


NCT ID

NCT05086016

Organization ID

PTC-0009


Responsible Party

Sponsor

Study Sponsor

Renata Medical


Study Sponsor

, , 


Verification Date

October 2021