What is the mechanism of action of this treatment?

The most common treatments for Pulmonary Artery Stenosis include the use of stents, such as the Minima Stent, which mechanically support the blood vessels to keep them open. These stents work by providing a scaffold that prevents the artery from narrowing, ensuring adequate blood flow through the pulmonary artery. This is crucial for patients with Pulmonary Artery Stenosis as it helps to reduce the pressure on the right side of the heart, improve oxygenation, and alleviate symptoms such as shortness of breath and fatigue. By maintaining vessel patency, stents can significantly improve the quality of life and overall prognosis for these patients.

What side effects are associated with this type of intervention?

The most common treatments for pulmonary artery stenosis involving mechanical support, such as stents, include the use of drug-eluting stents and balloon angioplasty. Known side effects of these treatments can include restenosis (re-narrowing of the artery), stent thrombosis (blood clot formation within the stent), and local vascular complications such as bleeding or vessel damage. Additionally, patients may experience reactions to the drugs used in drug-eluting stents, such as inflammation or delayed healing. It is important to monitor for these side effects and manage them promptly to ensure the best outcomes.

What prior FDA approvals exist?

The FDA has approved various stents for the treatment of vascular conditions, including those affecting the pulmonary artery. These stents are designed to keep blood vessels open and improve blood flow. While specific FDA approvals for pulmonary artery stenosis stents are not detailed, the use of stents like the Minima Stent in clinical trials suggests a focus on mechanical support for congenital vascular stenosis. Other similar devices include bare-metal stents and drug-eluting stents, which have been used in different vascular conditions to prevent restenosis and maintain vessel patency.

What other types of research exist?

Promising alternatives to the Minima Stent for Pulmonary Artery Stenosis include drug-eluting stents, such as those using paclitaxel or sirolimus, which have shown improved patency rates. Additionally, bioresorbable vascular scaffolds and covered stents are emerging as potential options due to their ability to reduce restenosis and provide temporary support while the vessel heals.

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Stent

Catheterized Stenting for Heart Problems

N/A

Waitlist Available

Research Sponsored by Renata Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions to materials in the stent (like cobalt-chromium), complications from antiplatelet/antithrombotic medications if aspirin or heparin are used post-procedure, and general risks associated with catheterization such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been on antibiotics for a bloodstream infection within the last 3 days.

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I have not been treated for endocarditis within the last 6 months.

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I have an aneurysm in my aorta or pulmonary artery where treatment is planned.

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My non-heart related illness may shorten my life to under six months.

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I have a genetic condition linked to blood vessel issues.

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I am allergic to aspirin or heparin and cannot take similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Endpoint

Primary Safety Endpoint

Secondary study objectives

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

Successful stent re-dilation at re-catheterization

Other study objectives

SAFETY: Free from Stent Fracture

Equipment Safety

SAFETY: Free from stent embolization or migration

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All treatedExperimental Treatment1 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).

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pulmonary Artery Stenosis include the use of stents, such as the Minima Stent, which mechanically support the blood vessels to keep them open. These stents work by providing a scaffold that prevents the artery from narrowing, ensuring adequate blood flow through the pulmonary artery. This is crucial for patients with Pulmonary Artery Stenosis as it helps to reduce the pressure on the right side of the heart, improve oxygenation, and alleviate symptoms such as shortness of breath and fatigue. By maintaining vessel patency, stents can significantly improve the quality of life and overall prognosis for these patients.