Growth Trial: Study of the Renata Minima Stent

NCT05086016 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: PTC-0009
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of the clinical investigation is to access 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.

Conditions

Coarctation of the Aorta; Pulmonary Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Demonstrating Clinical Success at 6 Months

  The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%. Clinical success is defined as: * Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months. * Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.

  Through 6-month follow-up Visit

• Number of Participants With Freedom From Serious Adverse Events at 6 Months

  The primary safety endpoint will be assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases: * Death * Cardiac arrest and/or emergency ECMO cannulation * Stroke * Limb loss * Vessel dissection of target lesion * Device thrombosis/occlusion * Cardiac perforation requiring percutaneous or open surgical intervention * Persistent cardiac arrhythmia requiring a pacemaker

  Through 6-month follow-up Visit

Secondary Outcomes (6)

• Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg

  immediately after deployment

• Successful Stent Re-dilation at Re-catheterization

  Immediately after re-dilation

• Number of Patients With Freedom From Stent Embolization or Migration at 6 Months

  6 months

• Number of Patients With Freedom From Stent Fracture at 6 Months

  6 months

• Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation

  90 days post re-dilation

Study Arms (1)

All treated

EXPERIMENTAL

The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).

Device: Catheterized Stenting

Interventions

Catheterized Stenting DEVICE

Catheterized stenting of vascular narrowings.

All treated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, acquired, or recurrent aortic coarctation, or
• native, acquired, or recurrent pulmonary artery stenosis \*As defined by the patient's medical team
• 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

You may not qualify if:

• 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 the location targeted for treatment
• Body weight \< 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
• Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
• Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
• 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

Sponsors & Collaborators

• Renata Medical: lead

Study Sites (7)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Boston Children's

Boston, Massachusetts, 02115, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's

Columbus, Ohio, 43205, United States

Location

Le Bonheur Children's

Memphis, Tennessee, 38103, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Sullivan PM, Zahn EM, Sathanandam S, Morray B, Shahanavaz S, Salavitabar A, Armstrong AK, Porras D, Berman DP. Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children. Circ Cardiovasc Interv. 2025 Dec;18(12):e015618. doi: 10.1161/CIRCINTERVENTIONS.125.015618. Epub 2025 Oct 10.

  PMID: 41070410 DERIVED

MeSH Terms

Conditions

Aortic Coarctation; Stenosis, Pulmonary Artery

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dali Alarian
• Organization: Renata Medical

dali@renatamedical.com

8553184988

Study Officials

• Darren Berman, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: January 14, 2021
• Primary Completion: February 26, 2024
• Study Completion (Estimated): March 30, 2028
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)