Catheterized Stenting for Heart Problems

Not currently recruiting at 6 trial locations

Overseen By Jordan Roy

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Renata Medical

Must not be taking: Antibiotics, Antiplatelets, Antithrombotics

Disqualifiers: Infection, Endocarditis, Aneurysm, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Minima Stent, a small device designed to improve blood flow in children with specific heart issues, such as narrowing of the aorta or pulmonary artery. These conditions can hinder the heart's ability to pump blood, causing various health problems. The trial seeks young patients needing treatment for these narrowed vessels and having at least one open vein or artery suitable for the procedure. Participants should not have active infections, certain genetic conditions, or be severely underweight. As an unphased trial, this study provides a unique opportunity for patients to access potentially beneficial treatments not yet widely available.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity to aspirin or heparin and cannot be treated with other similar medications, you may not be eligible to participate.

What prior data suggests that the Minima Stent is safe for neonates, infants, and young children?

Research has shown that the Minima Stent was well-tolerated in past studies. These studies found no serious side effects, such as early death, linked to the stent, suggesting it is generally safe. The Minima Stent also showed promising results in treating heart problems in infants and young children. Early testing indicated that the stent was both safe and effective for this group. Overall, the evidence suggests that the Minima Stent is a safe option for young patients with heart issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for heart problems involving narrowed or blocked arteries typically involve traditional stents, which are small mesh tubes inserted into the artery to keep it open. However, the Minima Stent is unique because it employs a catheterized delivery system that allows for more precise placement in the affected artery. Researchers are excited about this treatment because its innovative design may minimize complications associated with stenting, such as artery damage during insertion or stent migration. Additionally, the Minima Stent's potential for easier and safer deployment could lead to better patient outcomes compared to current options.

What evidence suggests that the Minima Stent is effective for congenital vascular stenosis?

Research has shown that the Minima Stent, which participants in this trial will receive, holds promise for treating common blood vessel narrowing in young patients, such as infants and children. In one study, doctors successfully placed the Minima Stent in 97.6% of cases, with 41 out of 42 patients having the stent correctly positioned. Another study found the stent safe and effective for treating conditions like coarctation of the aorta (narrowing of the main artery from the heart) and pulmonary artery stenosis (narrowing of the lung artery) in a small group of young patients. These findings suggest that the Minima Stent could be a reliable option for young patients needing treatment for these conditions. ^{1 4 5 6 7}

Who Is on the Research Team?

Darren Berman, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for young patients needing treatment for certain heart vessel narrowings like aortic coarctation or pulmonary artery stenosis. They must have specific measurements of adjacent vessels and accessible veins or arteries for the procedure. Exclusions include hypersensitivity to certain drugs, active infections, aneurysms at the treatment site, very low body weight, multiple vessel conditions requiring stents simultaneously, and severe non-cardiac diseases.

Inclusion Criteria

I have at least one open and usable vein or artery in my leg, neck, or near my heart for treatment delivery.

I need treatment for a narrowing in my heart's aorta or pulmonary artery.

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

Exclusion Criteria

You weigh less than 1.5 kilograms.

I need stents in more than one of my blood vessels.

Currently participating in an investigational drug study or another device study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Renata Minima Stent for intervention in congenital vascular stenosis

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical success and freedom from serious adverse events

6 months

Multiple visits (in-person and virtual)

Re-dilation (if indicated)

Successful stent re-dilation at re-catheterization, if necessary, to ensure optimal stent performance

Immediate post-re-dilation

What Are the Treatments Tested in This Trial?

Interventions

• Minima Stent

Trial Overview The Growth Trial evaluates the safety and effectiveness of the Renata Minima Stent in neonates, infants, and children with congenital vascular stenosis. The study involves catheterized stenting to open narrowed blood vessels in these young patients.

How Is the Trial Designed?

Group I: All treated Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Renata Medical

Lead Sponsor

Trials

2

Recruited

140+

Published Research Related to This Trial

The Infinnium Paclitaxel-eluting stents demonstrated a high success rate of 98% in deployment among 196 patients with symptomatic coronary disease, indicating effective treatment for coronary artery lesions.

The study reported a low overall major adverse cardiac event rate of 8.1% at 12 months, with only 1% cardiac death and 5% myocardial infarction, suggesting that the stents are both safe and effective for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with paclitaxel-eluting Infinnium coronary stents. Ostovan, MA., Mollazadeh, R., Kojuri, J., et al.[2017]

In a study of 546 patients, drug-eluting stents (DES) used for non-FDA-approved indications showed a significant reduction in major adverse cardiac events at 12 months compared to bare metal stents (BMS), with rates of 16.7% for DES versus 23.6% for BMS.

The primary benefit of DES was a lower need for repeat revascularization procedures, indicating that DES can be both effective and safe for off-label use without increasing the risk of cardiac death or nonfatal myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of "off-label" utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. Roy, P., Buch, AN., Javaid, A., et al.[2018]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015618

Multicenter Pivotal Trial of the Minima Stent for Vascular ... Implant Procedure. Successful implantation of the Minima stent in the intended location occurred in 41 of the 42 patients (97.6%). Thirty-nine ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543198/

Preliminary testing and evaluation of the renata minima ... This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013006

Optimal Minimal Stent Area and Impact of ... CONCLUSIONS: Stent underexpansion in the LAD and LCX ostium was significantly associated with long-term outcomes in patients who underwent up- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10106663/

Long‐term outcomes after stent implantation in very small ... Angiographic data were measured using quantitative coronary angiography analysis, including RVD, minimum lumen diameter, and percent of stenosis ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ccd.31074

Results of the multicenter early feasibility study (EFS) ... Implantation of the Renata Minima stent was safe and effective for the treatment of BPAS and CoAo in this small cohort of infants and young children during ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240003B.pdf

Summary of Safety and Effectiveness Data (SSED) Results No clinically significant adverse events leading to early death or mortality due to treatment with the Minima Stent were observed by ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05086016

Growth Trial: Study of the Renata Minima Stent 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% ...