Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05575245
Other study ID # XuanwuH135
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 3, 2022
Est. completion date October 20, 2024

Study information

Verified date December 2022
Source Xuanwu Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Prospective randomized controlled study to evaluate the difference of safety,effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.


Description:

Prospective randomized controlled study to evaluate the difference of safety,effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions. Patients with femoral-popliteal artery lesions in our department were randomly assigned to the Excimer Laser Ablation Combined Drug-coated Balloon group and drug-eluting stent group. Compare the ischemic improvement rate (limb salvage rate, postoperative patency rate) and the complications rate of two different treatments. At the same time, the peri-operative related factors that may affect the end point events, such as preoperative baseline data, lesion characteristics, imaging features, stent fracture, and end point observation indexes were analyzed by regression analysis.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 20, 2024
Est. primary completion date October 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: 1.all patients signed an informed consent form; 2.digital subtraction angiography (DSA) revealed femoropopliteal artery stenosis above 70% or occlusion resulting in claudication (Rutherford clinical category-Becker class II-III2-3) or critical limb ischemia (CLI) (Rutherford clinical category 4-5-Becker class IV-V) 3.with unobstructed vascular inflow; 4.with at least a vessel runoff; 5. good compliance and regular follow-up. Exclusion criteria: 1. Acute or subacute lower limb ischemia caused by acute intraluminal thrombus within the target lesion.; 2. Severe calcified lesions (grade 4 in the PACSS scale); 3. In-stent restenosis lesion or surgical arterial bypass grafting; 4. Severe renal insufficiency: creatinine level greater than 2.5 mg/dL; 5. Platelet count below 100,000/µL or with antiplatelet / anticoagulation contraindications; 6. Immunologic diseases or malignant diseases; 7. Ongoing active infection; 8. Decompensated congestive heart failure or acute coronary syndrome; 9. Refuse to sign the informed consent Unwillingness to comply with follow-up suggestions.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Drug-eluting Stent
Drug-eluting Stent angioplasty
Excimer Laser Ablation Combined Drug-coated Balloon
Excimer Laser Ablation Combined Drug-coated Balloon angioplasty

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary 12-month Primary Patency Rate systolic velocity ratio >2.4 as measured by Duplex ultrasound. 12 months
Secondary Technical success Technical success was defined as residual stenosis less than 30% by final 1 day
Secondary freedom from clinically-driven TLR it is defined as the freedom from clinically-driven target lesion revascularization 1 day
Secondary Major Adverse Events at 12-month Post Procedure Major adverse events included death, index limb ischemia, index limb amputation, 12 months
Secondary 12-month Limb Salvage Rate Limb Salvage is defined as the freedom from secondary major amputation 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05052918 - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Completed NCT05906797 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis. N/A
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Suspended NCT02932176 - Machine Learning for Handheld Vascular Studies
Recruiting NCT05158257 - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity N/A
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Recruiting NCT06230406 - T-Mem GEne in Atherosclerosis
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT02894931 - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed NCT02268513 - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Completed NCT03393377 - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination N/A
Completed NCT02224339 - New Technologies to Determine Carotid Plaque Vulnerability
Completed NCT02116829 - Is There Room for Butter in a Healthy Diet? N/A
Not yet recruiting NCT01923012 - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis Phase 2