Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06828770 · ClinicalTrials.gov registry record
Minima Stent System Post- Approval Study (PAS)
A clinical trial of Pulmonary Artery Stenosis and Aortic Coarctation, sponsored by Renata Medical.
- Recruiting
- Registry status
- 100
- Enrollment target
- 15
- Study locations
NCT06828770: Recruiting study of Pulmonary Artery Stenosis and Aortic Coarctation, sponsored by Renata Medical.
NCT06828770 is a study of Pulmonary Artery Stenosis and Aortic Coarctation that is actively recruiting participants, run by Renata Medical. The registered enrollment target is 100 participants. The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06828770, a study of Pulmonary Artery Stenosis and Aortic Coarctation, is actively recruiting participants, sponsored by Renata Medical.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 15
- Study locations
Study Summary
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.
Primary Outcome
Rate of Acute device success as defined by: * Stenosis relief, defined by stent outer diameter ≥ 75% of the normal surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent dysfunction at implantation
Conditions Studied
Interventions
- DEVICE Minima Stent System
Study Locations (15)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Texas
- Dell Children's Medical Center, The University of Texas at Austin - Austin
- Columbia Hospital at Medical City Dallas Hospital - Dallas
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Nicklaus Children's Hospital - Miami
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-05-21 |
| Est. Completion | 2031-12 |
What NCT06828770 shows while recruiting
NCT06828770 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Pulmonary Artery Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Minima Stent System is the first listed.
NCT06828770 lists 15 locations in 13 states (Ohio, Texas, California).
Frequently Asked Questions
What is clinical trial NCT06828770 about?
NCT06828770 is a clinical study titled "Minima Stent System Post- Approval Study (PAS)". This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-wor...
What is the current status of trial NCT06828770?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2025-05-21. Estimated completion is 2031-12.
What conditions does trial NCT06828770 study?
This clinical trial studies the following conditions: Pulmonary Artery Stenosis, Aortic Coarctation.
What interventions are being tested in trial NCT06828770?
The interventions under investigation include: Minima Stent System (DEVICE).
Who is sponsoring clinical trial NCT06828770?
This trial is sponsored by Renata Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06828770 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Artery Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI