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New treatment option for Coarctation of the Aorta
Official title Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial
ClinicalTrials.gov ID: NCT07316855
What this study is testing
- What it's testing
- A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 60
You may be able to join if
- Patient must between 1 and 60 years old Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA...
- diameter of adjacent normal segment of blood vessel×100% ) C：Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s
- The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.
- The patient's expected lifespan is more than one year after successful treatment with the stent.
- Reference vessel (diameter of the adjacent normal segment vessel ) diameter：4-16mm
You likely can't join if
- Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
- Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be...
- Patients with known allergy to contrast agent, iron and its degradation products.
- Patients with hemorrhagic disorders
- Patients with contraindications on antiplatelet agents and anticoagulant therapy.
- Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion.
See the full eligibility criteria
- Patient must between 1 and 60 years old Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA surgery，meanwhile meeting one of the following conditions: A：Pressure...
- diameter of adjacent normal segment of blood vessel×100% ) C：Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s
- The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.
- The patient's expected lifespan is more than one year after successful treatment with the stent.
- Reference vessel (diameter of the adjacent normal segment vessel ) diameter：4-16mm
- Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
- Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment.
- Patients with known allergy to contrast agent, iron and its degradation products.
- Patients with hemorrhagic disorders
- Patients with contraindications on antiplatelet agents and anticoagulant therapy.
- Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion.
- Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
- Target lesion to be treated where stent was implanted previously.
- Patients with severe stenosis or excessive tortuosity in the targeted vessel, or anatomical abnormalities, which predict the device will have difficulty reaching the target lesion.
- Other conditions that are unfavorable for stent delivery or balloon expansion.
- Patient who have already participated in another clinical trial, and have not yet completed or withdrawn within 3 months before the screening period of this trial.
- Patients who are not suitable for participating the trial as per investigator judgement.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.