Clinical trial NCT04365062: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis of Artery
In-stent Arterial Restenosis
Keywords: Excimer laser
drug coated balloon
femoropopliteal
In-stent Restenosis
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Primary Patency Rate
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: freedom from clinically-driven TLR
timeFrame: 12 months
measure: Major Adverse Events
timeFrame: 12 months
measure: Limb Salvage Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gu Yong Quan
state: Beijing
Study officials:
References:
citation: Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.