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)

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

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

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis of Artery; In-stent Arterial Restenosis
• Intervention / Treatment: Device: Excimer laser and drug coated balloon; Device: Excimer laser and plain balloon; Device: plain balloon and drug coated balloon

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

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Gu Yong Quan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention: Excimer laser and drug coated balloon; Intervention: Excimer laser and drug coated balloon group	Device: Excimer laser and drug coated balloon; Excimer laser and drug coated balloon
ACTIVE_COMPARATOR: Excimer laser and plain balloon; Excimer laser and plain balloon group	Device: Excimer laser and plain balloon; Excimer laser and plain balloon
ACTIVE_COMPARATOR: plain balloon and drug coated balloon; plain balloon and drug coated balloon group	Device: plain balloon and drug coated balloon; plain balloon and drug coated balloon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (ACTUAL): April 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: In-stent Restenosis; drug coated balloon; femoropopliteal; Excimer laser
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: FPA-ISR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No