Ilio-femoral arterial disease LEAD, TRA, TFA, EVT
Conditions
Interventions
Sponsors
Nakamura Masato
Nakamura Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with LEAD due to symptomatic AI lesions who are scheduled for endovascular treatment are eligible Patients who meet all of the following criteria will be considered Patients 20 years of age or older Patients with intermittent claudication AI lesions (if lesions are present below the inguinal ligament, initial treatment should be limited to AI lesions only) Patients deemed by the surgeon to be eligible for both TRA/TFA Patients whose written consent is obtained from the patient
Exclusion criteria
Exclusion criteria: Patients who are thought to have a life expectancy of 2 years or less Female patients who are pregnant or planning to become pregnant Patients who have had or are having a hemorrhagic stroke within 3 months prior to the procedure Patients who have received thrombolytic therapy within 30 days prior to the procedure Patients who have undergone surgery (surgical procedure, endovascular treatment, etc.) within 15 days prior to the procedure or are scheduled to undergo surgery within 30 days after the procedure Patients with drug hypersensitivity syndrome or contraindication to antiplatelet agents or cilostazol (or similar agents) required in this clinical study Patients with bleeding (hemophilia, capillary fragility, intracranial bleeding, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous bleeding, etc.) Patients with congestive heart failure. Patients allergic to contrast media Patients who are currently participating or will participate in other clinical trials Patients who are unable to walk unassisted Patients on or scheduled for hemodialysis Patients with bilateral common iliac lesions contiguous from the aorta Patients with a history of surgical revascularization or major amputation of the lower extremity, whether ipsilateral or contralateral Stent restenotic lesions Patients deemed inappropriate in the physician's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from puncture to start of ambulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success rate: completion of procedure without crossover Walking ability 5 minutes after sheath removal Time from puncture to discharge Time from sheath removal to discharge Time from sheath removal to bed release Manual compression time in the catheterization room Hemostasis time Success rate of hemostatic devices Pseudoaneurysm/hematoma after release of pressure Length of hospital stay Cost of treatment Patient satisfaction (SF-8) Vascular complications confirmed by body surface echocardiography Major adverse cardiac events at 30 days postoperatively Major adverse cardiac, cerebral, and limb events (MACLE: major adverse cardiac, cerbebrotic, and limb events) and BARC (Bleeding Academic Research Consortium) 2, 3, 5 bleeding complications and puncture site-related complications at 30 days postoperatively Composite endpoint of site-related complications | — |
Contacts
Public ContactMasato Nakamura
Toho University
Outcome results
None listed