Prospective, multicenter, single-arm clinical trial to value the safety and efficacy of Rotablator atherectomy system as an adjunctive device for the endovascular treatment of occlusive atherosclerotic lesions in the below the knee with critical limb ischemia. - RESCUE BTK trial

RESCUE Clinical Trial Office0 sites17 target enrollmentOctober 27, 2017

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2017

End Date

May 28, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

RESCUE Clinical Trial Office

•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.

•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.