DIAbetes Maximal ACCeleration
Peripheral Arterial DiseaseDiagnosis1 morePrevalence of diabetes mellitus (DM) is increasing rapidly, with patient numbers projected to rise to 643 million by 2030. As a consequence of diabetes-related atherosclerosis, peripheral arterial disease (PAD) and in particular medial arterial calcification (MAC) can occur. The accurate identification of PAD by bedside tests is extremely important in patients with diabetes and foot ulceration, in order to reduce delayed wound healing, prevent lower limb amputation and eventually reduce mortality. However, as shown in previous systematic reviews, the performance of current bedside tests is not reliable in excluding PAD in diabetic patients.1,2 Moreover, the methodological quality of the conducted studies is generally poor. Therefore, more reliable and prospective data is required. Also alternative bedside tests need to be investigated. As an example, the ACCmax (a new doppler derived parameter) could be particularly promising in this patient group.
Feasibility Study With the Sirolimus-Eluting BX Velocity Balloon-Expandable Stent in the Treatment...
Peripheral Vascular DiseasesThe main objective of this study is to assess in-stent late lumen loss in diabetic patients with de novo native coronary lesions using the sirolimus-eluting Bx VELOCITYä stent as compared to the Bx VELOCITY balloon-expandable stent.
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities...
Peripheral Arterial DiseaseThe goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Peripheral Vascular DiseasesTo compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Prehabilitation for PAD Revascularization Patients
Peripheral Vascular DiseasePeripheral Artery DiseasePatients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.
The Isthmus Logic Post Market Clinical Follow-up Study
Peripheral Arterial DiseaseIsthmus Logic Carbostent™ is a CE-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease. The aim of this post-market retrospective study protocl P22202 is to collect clinical data of patients treated with Isthmus Logic for the treatment of peripheral iliac artery disease in routine clinical practice. In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.
Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment
Peripheral Arterial DiseaseThe aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.
BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions...
Peripheral Arterial DiseaseA Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions. The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used according to the indications of the IFU.
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
Peripheral Arterial DiseaseThe purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal arteries (PPA).
Oral Nutritional Supplement in Reducing Surgical Site Infections
Peripheral Vascular DiseaseClaudicationThe study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement in the prevention of wound complications in the the wounds of patients post lower limb revascularization.