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

Phase 3

Completed

• Conditions: nsuccessful balloon angioplasty for below-the-knee occlusive atherosclerotic lesions with critical limb ischemia

• Registration Number: JPRN-jRCT1090220313
• Lead Sponsor: RESCUE Clinical Trial Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-27
• Study Completion: 2020-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified