Lower Extremity Artery Disease
Conditions
Interventions
None listed
Sponsors
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with lower extremity artery disease who have severely calcified lesions in the femoropopliteal artery on angiography, defined as more than or equal to 70% diameter stenosis and classified as Peripheral Arterial Calcium Scoring System grade 3 or 4. 2) Patients who underwent elective endovascular therapy using debulking devices followed by drug-coated balloon angioplasty under optical frequency domain imaging guidance after the study approval date. 3) Patients aged 20 years or older at the time of informed consent. 4) Patients who are able to understand the treatment procedures and the objectives of the study and to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with a life expectancy of less than 1 year due to terminal illness. 2) Patients with acute limb ischemia or acute thrombosis. 3) Patients with in-stent restenosis or occlusion lesions. 4) Patients with Rutherford Category 6, or critical limb ischemia with suspected extensive infection. 5) Patients with lesions at the anastomosis site after bypass surgery. 6) Patients unable to continue antiplatelet therapy (e.g., patients scheduled for surgery requiring withdrawal of antiplatelet agents within 1 month). 7) Patients who are pregnant, breastfeeding, or possibly pregnant. 8) Other patients judged inappropriate for enrollment by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency at 12 months after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Primary patency at 24 months 2) The following outcomes at 12 and 24 months: 1. Freedom from restenosis assessed by duplex ultrasound 2. Target Lesion Revascularization 3. Target Vessel Revascularization 4. Conversion to surgical revascularization 5. Occurrence of acute thrombotic occlusion 6. Major amputation (defined as amputation proximal to the ankle) 7. Major Adverse Limb Events 8. Rutherford classification 9. Initial procedural success rate 10. Incidence of adverse events: (1) All-cause mortality (2) Cardiovascular mortality (3) Stroke / Systemic embolism (4) Hospitalization for cardiac causes (5)Intracranial hemorrhage 3) Occurrence of distal embolization after debulking device treatment 1. True distal embolization (Angiographic distal embolization) 2. Clinically significant distal embolization (requiring additional treatment or causing symptoms) 3. Resolved distal embolization (improved by treatment or spontaneously) 4. Unresolved distal embolization | — |
Countries
Japan
Contacts
Public ContactTakayoshi Toba
Kobe University Graduate School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine
Outcome results
None listed