A study in patients with a sudden blood clot in the leg, to remove this clot using the Indigo™ aspiration system.
Zusammenfassung der Studie
This study concerns a serious medical problem called acute limb ischemia. This occurs when blood suddenly stops flowing in the vessels of the legs, which can damage tissues. One possible treatment is to remove the blood clot using a special device called the Indigo™ aspiration system. This system helps to clear blocked vessels so that blood can flow again. The goal is to protect the tissues, prevent the situation from worsening, and help the patient recover. This study aims to verify the safety and efficacy of this treatment. The Indigo system is a medical device approved in the United States (by the FDA) and in Europe (CE certification). Up to 300 patients in approximately 50 hospitals worldwide will participate in this study. The study will last about 4 years. Each patient will be followed for 6 months, with scheduled visits or calls: - at hospital discharge (or after 7 days, whichever comes first) - 30 days after the procedure - 180 days (6 months) after the procedure
(BASEC)
Untersuchte Intervention
Under anesthesia, a small incision is made in the groin or another area of the body. Subsequently, catheters, flexible tubes, are inserted into a blood vessel. These catheters are then guided through the vessel to the location of the clot in the affected area, usually at the level of the legs.
At this stage, a dye is injected into the blood vessel to allow for imaging, to visualize the flow of the dye and identify any obstructions. The severity of the obstruction will be assessed and may be measured multiple times during the procedure to ensure accurate monitoring. Then, the Indigo aspiration system is used to suction the blood clot, restoring blood circulation. After the clot is removed, images are taken to reassess blood flow. The aspiration system is then removed from the body.
Pressure is applied to the incision site to control any bleeding. The images taken during the procedure, as part of routine care, will be sent to the sponsor for analysis as part of the clinical study.
(BASEC)
Untersuchte Krankheit(en)
acute limb ischemia
(BASEC)
1. Be 18 years of age or older. 2. Have a confirmed diagnosis of a blocked artery in the leg, starting from the common iliac artery or lower, with at least 2 cm of open artery before the blockage. 3. Have a recent occlusion (blockage), with symptoms that appeared within the last 14 days. 4. Be in one of the following categories according to the Rutherford classification for acute limb ischemia (ALI): category I, IIa, or IIb (which means reduced but still recoverable circulation). 5. Treatment must begin with the Indigo aspiration system, using computer-assisted technology called CAVT. 6. Informed consent must be obtained, either directly from the patient or from their legal representative, according to the ethics committee rules. 7. A participant already enrolled may participate again if they develop a new occlusion in the other leg, at least 30 days after the first treatment, provided they still meet all eligibility criteria. (BASEC)
Ausschlusskriterien
1. The patient has a life expectancy of less than one year. 2. The blood vessel to be treated is very small (less than 2 mm in diameter). 3. The clot is located in the aorta or an isolated deep artery. 4. The patient has had a major amputation (near the foot) in the affected leg. 5. The patient has had a minor amputation in the affected leg in the last 6 months that is not fully healed or does not allow walking. 6. The ischemia (lack of blood) is due to dissection, inflammation of the vessels (vasculitis), or trauma (accident or injury), including if it is due to medical treatment. 7. The clot is located in a venous bypass (such as a graft using the saphenous vein). 8. The patient has already been treated for this episode with medications to dissolve the clot or another intervention (surgical or endovascular) before being included in the study. 9. The patient is pregnant. 10. The patient is allergic or cannot receive the iodinated contrast agent used for imaging and cannot receive preventive medication. 11. The patient has medical, psychological, or behavioral issues that, in the physician's opinion, prevent proper consent or make participation in the study difficult (such as adhering to follow-up appointments), or that could bias the study results. 12. The patient is already participating in another study with an experimental drug or device, which could influence the results. (Follow-up studies for products already available on the market do not count as experimental.) (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
Rede Optimus Hospitaler AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Marie-Hélène Théret
+32 472 588 502
mtheret@clutterpenumbrainc.comPenumbra Inc.
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
26.01.2026
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the IndigoTM Aspiration System (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Ergebnisse der Studie
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