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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Excellent：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

Conditions
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Atherosclerosis of Artery, In-stent Arterial Restenosis

Intervention / Treatment
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* Device: Excimer laser and drug coated balloon
* Device: Excimer laser and plain balloon
* Device: plain balloon and drug coated balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Excimer laser and drug coated balloon<br>Intervention: Excimer laser and drug coated balloon group | Device: Excimer laser and drug coated balloon<br>* Excimer laser and drug coated balloon<br>|
| Active Comparator: Excimer laser and plain balloon<br>Excimer laser and plain balloon group | Device: Excimer laser and plain balloon<br>* Excimer laser and plain balloon<br>|
| Active Comparator: plain balloon and drug coated balloon<br>plain balloon and drug coated balloon group | Device: plain balloon and drug coated balloon<br>* plain balloon and drug coated balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency Rate | Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.4 as measured by Duplex ultrasound. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection. | 1 day | 
| freedom from clinically-driven TLR | it is defined as freedom from clinically-driven target lesion revascularization | 12 months | 
| Major Adverse Events | Major adverse events included death, index limb ischemia, index limb amputation, and significant embolic events, which were defined as causing end-organ damage. | 12 months | 
| Limb Salvage Rate | Limb Salvage is defined as the freedom from secondary major amputation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excimer laser, drug coated balloon, femoropopliteal, In-stent Restenosis