Unsuccessful balloon angioplasty for below-the-knee occlusive atherosclerotic lesions with critical limb ischemia
Conditions
Interventions
Intervention type:DEVICE,PROCEDURE
Name of intervention:Percutaneous transluminal rotational atherectomy
Dose form / Japanese Medical Device Nomenclature:DEVICE
Rotablator atherectomy system (NCVC-BR2
Sponsors
RESCUE Clinical Trial Office
Kasukabe Central General Hospital, Kanazawa Medical University Hospital, Kishiwada Tokushukai Hospital, Kyoto-Katsura Hospital, Kyoto Prefectural University of Medicine
Kumamoto University Hospital, National Cerebral and Cardiovascular Center, Hyogo Prefectural Amagasaki General Medical Center, University of Fukui Hospital, Rakuwakai Otowa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provisional registration 1. Rutherford category 4 or 5 due to atherosclerotic peripheral artery disease. 2. SPP less than 50mmHg below ankle joint. 3. Presence of one or more risk factors as follows: Diabetes, maintenance dialysis (hemodialysis or peritoneal dialysis), renal failure (eGFR less than 60ml/min/1.73m2), age 65 years or more, presence of calcification in below-the-knee arteries. 4. Age 20 years or more at the time of informed consent. 5. Agreement for participating in the study and written informed consent provided by the patients or legally acceptable representative. 2) Definitive registration 1. Unsuccessful balloon angioplasty for target lesion within 2 weeks prior to the definitive registration. 2. Presence of calcification in the target lesion. 3. Target lesion between the distal popliteal artery and the distal crural artery. 4. Target lesion with visual reference vessel diameter 2.0 to 4.0 mm. 5. Target lesion length less than 100mm.
Exclusion criteria
Exclusion criteria: 1) Provisional registration 1. Inability to receive contract agents. 2. History of amputation above knee joint, or planning major amputation surgery of the target lower limb. 3. Prior bypass surgery to the target lower limb 4. Prior stent implantation in target vessel. 5. Prior endovascular intervention to the non-target vessel of the target lower limb within 1 week prior to provisional registration. 6. Prior enrollment of this trial . 7. Patients with severe wound inflammation or with any severe infectious disease. 8. History of myocardial infarction, ischemic stroke, intracranial hemorrhage within 6 months prior to provisional registration. 9. Non-dialysis patient with serum creatinine level 2.0 mg/dL or more. 10. Any abnormal blood test: Platelet count less than 80,000 /uL or 600,000 /uL or more, white blood cell less than 3,000 /uL, or hemoglobin less than 8.0 g/dL. 11. Inability to move by wheelchair. 12. Life expectancy of less than 1 year. 13. Pregnant, breastfeeding or possibly pregnant women. 14. Contraindication to antiplatelet medications. 15. Participating or planning to participate in other clinical trials or interventional studies. 16. Any other reason, based on the investigator's discretion. 2) Definitive registration 1. Failed target lesion passage of guidewire. 2. Angiographic thrombus. 3. High risk for arterial perforation by trial procedures based on the investigator's discretion. 4. Prior endovascular intervention to non-target vessel of the target lower limb within 1 week prior to definitive registration. 5. Prior enrollment of this trial. 6. Any other reason based the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success rate of balloon angioplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Primary Efficacy Endpoint 1. Change in residual diameter stenosis by quantitative vessel analysis (Core Lab) 2. Limb-salvage rate of the trial leg 3. Amputation-free survival 4. Change in visual analog scale (VAS) 5. Change in ankle-brachial index (ABI) 6. Change in skin perfusion pressure (SPP) 7. Change of Rutherford classification 8. Wound assessment 9. Change in residual diameter stenosis by visual estimation (on site) 10. successful lesion pass rate 2) Primary safety endpoint 1. Number of distal embolization after angioplasty 2. Number of re-occlusions after angioplasty 3. Number of serious adverse event (SAE) associated with the trial procedures 4. Number of deaths 5. Number of cardiovascular events 6. Number of major adverse limb events 7. Number of target vessel revascularization | — |
Countries
Japan
Contacts
Public ContactShin Ito
National Cerebral and Cardiovascular Center
Outcome results
None listed