Ongoing Clinical Trials for Arterial Disorder
There are currently 2 ongoing clinical trials investigating treatments for arterial disorders. These studies are exploring different medications for conditions affecting blood vessels in the legs and brain, aiming to improve outcomes for patients with these vascular problems.
Clinical trial locations
- Austria
- Denmark
- France
- Germany
- Poland
- Sweden
Study on Colchicine for Preventing Artery Narrowing in Patients with Lower Extremity Artery Disease
This trial is investigating whether colchicine, a medication taken orally as a film-coated tablet, can help prevent arteries from becoming narrow again after treatment. The study focuses on the superficial femoral artery, an important blood vessel in the thigh that supplies blood flow to the lower leg.
Who can participate:
- Adults older than 30 years
- Patients with chronic lower limb ischemia, which means reduced blood flow to the legs, classified as grade 3 to 5 according to the Rutherford classification
- Those with a blockage or narrowing of 50% or more in the superficial femoral artery, confirmed through arteriography, with an ankle-brachial index less than 0.90
- The affected area must be at least 1 cm away from the start of the deep femoral artery and not more than 3 cm above the kneecap
- The diameter of the affected blood vessel should be between 4.0 mm and 7.0 mm
- The popliteal artery and at least one artery in the calf must be open and not blocked
- Women must be postmenopausal or have had surgery to prevent pregnancy, and agree to use two forms of birth control
- Men must agree to use a condom or avoid heterosexual intercourse during the study
- Participants must agree to provide a blood sample for genetic testing
Who cannot participate:
- Pregnant or breastfeeding women
- People with severe liver or kidney problems
- Those with a history of allergic reactions to colchicine or similar medications
- Individuals who have had a heart attack or stroke in the last 6 months
- Patients with uncontrolled high blood pressure
- Those currently taking certain medications that interact with colchicine
- People with active infections or serious illnesses
- Individuals with a history of alcohol or drug abuse
- Those who have participated in another clinical trial within the last 30 days
- Individuals with mental health conditions that affect their ability to follow study instructions
Focus of the trial: The main goal is to determine whether colchicine can prevent restenosis, which is when an artery becomes narrow again after treatment. Participants will receive either colchicine or treatment with a stent, including some stents that release paclitaxel medication. The study will monitor the health of the artery using ultrasound examinations and other methods over a period of up to 24 months. Researchers will assess effectiveness, safety, improvements in blood flow, and quality of life.
Investigational drugs: Colchicine is an oral anti-inflammatory medication being studied for its ability to prevent the superficial femoral artery from narrowing again after stent placement. It works by disrupting microtubule formation, which affects cell division and reduces inflammation. Paclitaxel is used in drug-eluting stents to locally release medication and prevent restenosis. It works by stabilizing microtubules, which stops cells from dividing and reduces the growth of cells that could cause artery narrowing.
Study on High-Dose Methylprednisolone and Prednisolone for Children with Stroke Due to Focal Cerebral Arteriopathy
This clinical trial is studying the effects of high-dose steroid medications in children who have experienced a stroke caused by focal cerebral arteriopathy, an inflammatory condition that causes narrowing of blood vessels in the brain. The study aims to find out whether early anti-inflammatory treatment can improve the condition of blood vessels and prevent further strokes.
Who can participate:
- Children between 6 months and 18 years of age at the time of stroke
- Those who can be randomly assigned to a treatment group within 48 hours of diagnosis and no later than 96 hours after stroke onset
- Children with unilateral arteriopathy, meaning a problem with blood vessels on one side of the brain, confirmed by newly appearing neurological problems and specific findings on brain scans showing narrowing or irregularities in blood vessels
- For female participants aged 13 and older, a negative pregnancy test is required
- The legal representative of the child must give written permission for participation
Who cannot participate:
- Children with other serious health conditions that could interfere with the study
- Those currently taking medications that might affect study results
- Children who have had a recent infection that could impact the study
- Those with a history of allergic reactions to the study medications
- Children unable to follow study procedures or attend follow-up visits
- Those participating in another clinical trial at the same time
- Children with conditions that study doctors believe would make participation unsafe
Focus of the trial: The study will monitor changes in the severity of the arteriopathy over time, improvements in neurological function, and whether strokes recur. Participants will receive either steroid treatment or a placebo, in addition to standard care that includes treatments to prevent blood clots. The primary outcome is measured by changes in severity score from the start of the study to 1 month later. The study will also assess neurological deficits over time, neurocognitive outcomes at 12 months, and residual blood vessel problems at 6 months. Follow-up assessments will continue for several months.
Investigational drugs: Methylprednisolone is a steroid medication given either into a vein or taken orally to reduce inflammation in blood vessels. It works by suppressing the immune system’s response, decreasing inflammation at a molecular level. Prednisolone is another steroid taken orally in tablet form that also reduces inflammation by inhibiting the immune system’s inflammatory response. Both medications are corticosteroids being studied to see if they can improve blood vessel health in children who have experienced a stroke, potentially preventing future strokes.
Summary
These two clinical trials represent different approaches to treating arterial disorders in distinct patient populations. One study focuses on adults with leg artery disease in Poland, testing whether colchicine can prevent arteries from narrowing again after treatment. The other is a multi-country European study spanning France, Austria, Germany, Sweden, and Denmark, investigating high-dose steroids for children who have suffered strokes due to blood vessel inflammation in the brain.
Both trials share a common goal of improving blood vessel health and preventing complications, though they target different age groups and different parts of the vascular system. The pediatric stroke study has a broader geographic reach across multiple European countries, while the leg artery disease study is currently being conducted in Poland. Both studies emphasize careful monitoring of participants and assessment of safety alongside effectiveness.
