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

Atherosclerosis of Artery Clinical Trial

— Excellent  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365062
• Other study ID #: FPA-ISR
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: Xuanwu Hospital, Beijing
• Contact: li yang
• Phone: 17198643706
• Email: 1093075829[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Artery
• In-stent Arterial Restenosis

Intervention

Device:
• Excimer laser and drug coated balloon
Excimer laser and drug coated balloon
• Excimer laser and plain balloon
Excimer laser and plain balloon
• plain balloon and drug coated balloon
plain balloon and drug coated balloon

Locations

Country	Name	City	State
China	Gu Yong Quan	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical success	Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.	1 day
Secondary	freedom from clinically-driven TLR	it is defined as freedom from clinically-driven target lesion revascularization	12 months
Secondary	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
Secondary	Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months