Catheterized Stenting for Heart Problems

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

42 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Minima Stent for heart problems?

Research shows that using stents (tiny tubes placed in blood vessels) in heart procedures can improve blood flow and have successful immediate outcomes, as seen in patients with heart attacks and coronary heart disease. These studies suggest that stenting, like the Minima Stent, can be effective in treating heart problems by widening narrowed arteries. ^{1 2 3 4 5}

Is catheterized stenting generally safe for humans?

Research on various types of stents, including drug-eluting stents, shows that they are generally safe with low rates of major adverse cardiac events like heart attacks or the need for additional procedures. However, there have been some concerns about stent thrombosis (blood clots forming in the stent) and other complications, but these are relatively rare. ^{6 7 8 9 10}

How is the Minima Stent treatment different from other treatments for heart problems?

The Minima Stent is unique because it is designed for use in very small coronary vessels, which can be challenging to treat with standard stents. This newer-generation stent may offer better outcomes for patients with small vessel coronary artery disease by providing a more suitable fit and potentially reducing complications. ^{6 11 12 13 14}

What is the purpose of this trial?

This trial is testing a small tube-like device called the Minima Stent. It is designed for babies and young children who have narrow blood vessels. The stent helps keep these vessels open, allowing better blood flow.

Research Team

Darren Berman, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Intracoronary stents in small vessels: short- and long-term clinical results]. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Coronary artery stenting in acute myocardial infarction. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of coronary stent intervention for coronary heart disease and its impact on short-term and long-term prognosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Long stenting in native coronary arteries: relation between vessel size and outcome. [2019]

5. India pubmed.ncbi.nlm.nih.gov

Restenosis after coronary stenting--incidence and predictors. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

The EXTREME registry: titanium-nitride-oxide coated stents in small coronary arteries. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Experience with paclitaxel-eluting Infinnium coronary stents. [2017]

8. Japan pubmed.ncbi.nlm.nih.gov

Cardiac damage after carotid intervention: a meta-analysis after a decade of randomized trials. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of "off-label" utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Coronary Intervention for Very Small Vessels With the Use of a Newer-Generation 2.0 mm Drug-Eluting Stent. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Bare delivery of medium and large stents in patients with congenital heart disease. [2012]

13. United States pubmed.ncbi.nlm.nih.gov

Unprotected left main bifurcation restenosis treated with a 2-stent technique. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Stenting unprotected left main coronary artery stenosis in heart transplant patients--the good, bad, and the ugly. [2019]