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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Gu Yong Quan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention: Excimer laser and drug coated balloon
Intervention: Excimer laser and drug coated balloon group
|
Excimer laser and drug coated balloon
|
|
ACTIVE_COMPARATOR: Excimer laser and plain balloon
Excimer laser and plain balloon group
|
Excimer laser and plain balloon
|
|
ACTIVE_COMPARATOR: plain balloon and drug coated balloon
plain balloon and drug coated balloon group
|
plain balloon and drug coated balloon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Patency Rate
Time Frame: 12 months
|
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
Time Frame: 1 day
|
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
Time Frame: 12 months
|
it is defined as freedom from clinically-driven target lesion revascularization
|
12 months
|
|
Major Adverse Events
Time Frame: 12 months
|
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
Time Frame: 12 months
|
Limb Salvage is defined as the freedom from secondary major amputation
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPA-ISR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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