Clinical Study of Excimer Laser and Drug Coated Balloon Versus Excimer Laser and Plain Balloon Versus Plain Balloon and Drug Coated Balloon to Treat Femoropopliteal In-stent Restenosis (Excellent)

Capital Medical University

Status: Unknown

Conditions: In-stent Arterial Restenosis; Atherosclerosis of Artery

Treatments: Device: plain balloon and drug coated balloon; Device: Excimer laser and drug coated balloon; Device: Excimer laser and plain balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04365062

FPA-ISR

Details and patient eligibility

About

This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis

Full description

This is a randomized study comparing Excimer laser and drug coated balloon Versus Excimer laser and plain balloon versus plain balloon and drug coated balloon to Treat femoropopliteal in-stent restenosis

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with >50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.

Exclusion criteria

They were excluded if they had one or more of the following: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Intervention: Excimer laser and drug coated balloon

Experimental group

Description:

Intervention: Excimer laser and drug coated balloon group

Treatment:

Device: Excimer laser and drug coated balloon

Excimer laser and plain balloon

Active Comparator group

Description:

Excimer laser and plain balloon group

Treatment:

Device: Excimer laser and plain balloon

plain balloon and drug coated balloon

Active Comparator group

Description:

plain balloon and drug coated balloon group

Treatment:

Device: plain balloon and drug coated balloon