Comparison of treatment outcomes of balloon dilation of stenoses of the leg arteries with drug-coated and uncoated balloon catheters
Résumé de l'étude
This study investigates patients with a vascular stenosis of the leg arteries that affects blood supply. We conduct this study to compare whether the dilation of the vascular stenosis using a drug-coated balloon catheter is similarly effective or better than with an uncoated balloon catheter. We aim to compare the efficacy, safety, and tolerability of common balloon catheters. Uncoated balloons have been used for decades to treat vascular stenoses. Coated balloons contain a drug on the balloon surface, which is pressed into the vessel wall during the dilation of the balloon in the narrowed vessel. The drug remains in the vessel wall for several weeks and is intended to prevent the re-narrowing of the vessel due to excessive scar formation by inhibiting cell growth. The drug used here is Sirolimus, which aims to prevent cell overgrowth and thus the re-narrowing of the affected vessel. Sirolimus-coated vascular stents have been used for many years in obstructed coronary arteries with good results. Coated balloons have also been used for many years in obstructed leg arteries, but it has never been attempted to demonstrate whether this treatment has a benefit on relevant outcomes, including limb preservation (prevention of amputations) and repeated emergency interventions on the leg.
(BASEC)
Intervention étudiée
It is examined whether the dilation of the vascular stenosis using a drug-coated balloon catheter is similarly effective or better than with an uncoated balloon catheter.
(BASEC)
Maladie en cours d'investigation
This study investigates peripheral arterial occlusive disease. Affected patients suffer from a stenosis or occlusion of one or more leg arteries, which affects blood supply. This is treated endovascularly (i.e., from within through a small access, usually via the groin).
(BASEC)
- adult patients - patients for whom balloon dilation of an obstructed leg artery is planned - patients who give their consent to the study (BASEC)
Critères d'exclusion
- pregnant and breastfeeding women, or women who have planned a pregnancy - patients with a known intolerance to Sirolimus - patients participating in another clinical study (BASEC)
Lieu de l’étude
Fribourg, Zurich
(BASEC)
Sponsor
Universitätsspital Zürich, Klinik für Angiologie
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Rebecca Spescha
+41 43 253 03 71
rebecca.spescha@clutterusz.chUniversitätsspital Zürich Klinik für Angiologie Rämistrasse 100 8091 Zürich
(BASEC)
Informations générales
University of Zurich
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
05.03.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04238546 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty. The 'SirPAD' randomized controlled trial (BASEC)
Titre académique
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty (ICTRP)
Titre public
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty (ICTRP)
Maladie en cours d'investigation
Peripheral Arterial Disease (ICTRP)
Intervention étudiée
Device: sirolimus-coated balloon catheterDevice: uncoated balloon catheter (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Age > 18 years
- Patients requiring endovascular angioplasty for PAD located below the inguinal
ligament
- Written informed consent obtained from participant or legal guardian prior to
randomization in patients requiring emergency interventional treatment who are
temporarily not capable of providing informed consent, consent will be subsequently
obtained after the procedure if strict conditions apply. These include the
assessment of the presumed will and patient decree, and requires the allocation of
an independent physician
Exclusion Criteria:
- Pregnancy, breastfeeding, or planned pregnancy within the trial period or women of
childbearing potential not using an adequate method of contraception
- Patients with known intolerance or allergy to sirolimus
- Participation in this or other clinical trials during the previous 3 months (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
unplanned major amputation of the target limb;endovascular or surgical target lesion re-vascularization for critical limb ischemia (ICTRP)
composite of unplanned (major or minor) index-limb amputations or any target lesion re-vascularization within 365 days after enrolment (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Nils Kucher, Prof.;Rebecca Spescha, Dr. sc. nat, rebecca.spescha@usz.ch, +41432530371, University of Zurich, (ICTRP)
ID secondaires
SirPAD Trial (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04238546 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible