Lesion Preparation in Femoropopliteal Artery Occlusion Disease (CIVILIAN)

CIVILIAN Study in Femoropopliteal Artery Occlusion Disease

Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.

Study Overview

• Status: Recruiting
• Conditions: In-stent Restenosis; Femoropopliteal Artery Occlusion; Atherosclerosis Obliterans; Lesion; Vascular
• Intervention / Treatment: Device: conventional balloon; Device: lesion preparation devices

Detailed Description

Femoropopliteal artery occlusive disease is a common type of peripheral arterial disease (PAD). Hitherto, endovascular treatment has been testified and advocated as the first-line treatment of femoropopliteal occlusive disease. However, the in-stent restenosis has been a major limitation of well long-term patency rate in this segment due to physiological and geometrical issues. The concept "leave nothing behind" is proposed, and some vessel preparation methods and devices, such as directional atherectomy, rotational atherectomy, laser atherectomy are developed. This is a national, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions. A total of 1000 patients will be included in approximately 8 sites. The study is designed to demonstrate the inferiority of different vessel preparation strategies in various fields under long-term follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Bo Yu, M.D.; Phone Number: 18918922698; Email: paul.yubo@gmail.com
• Study Contact Backup: Name: Weihao Shi, M.D.; Phone Number: 13601982603; Email: vascular741021@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201200
      • Recruiting
      • Shanghai Pudong Hospital
      • Contact: Weihao Shi, M.D.; Phone Number: 13601982603; Email: vascular741021@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

• Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
• Patient has a score from 2 to 5 following Rutherford classification
• Unilateral or bilateral F-P occlusive lesions (enrollment of one or both target limbs depend on operators)
• Complete recanalization followed by POBA, Chocolate PTA, Scoring PTA, Shockwave PTA, SilverHawk, TurboHawk, Jetstream, Angiojet, Laser and Rotarex

Angiographic Inclusion Criteria:

• TASC II-Type A/B/C/D
• Iliac inflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)-less than 50% residual stenosis
• There is angiographic evidence of at least one-vessel-runoff (>10cm) to the foot

General Exclusion Criteria:

• Projected for major amputation of target limb (above ankle joint)
• Change to thrombectomy or bypass during operation
• Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated
• Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
• female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
• Life expectancy of less than twelve months.
• Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
• Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
• Patient unwilling or unlikely to comply with Follow-Up schedule

Angiographic Exclusion Criteria:

• Testified for acute F-P arterial embolization
• Thromboangiitis obliterans
• Failed for recanalization

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lesion preparation with POBA in femoropopliteal Artery occlusion; Patients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB.	Device: conventional balloon; Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.
lesion preparation with debulking devices in femoropopliteal Artery occlusion; Patients with femoropopliteal artery occlusion were treated by other lesion preparation devices, like Chocolate balloon, Shockwave balloon, TurboHawk, Jetstream and Rotarex and then followed by DCB.	Device: lesion preparation devices; successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty; Other Names: Chocolate balloon; Shockwave balloon; Rotarex; TurboHawk; Jetstream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from TLR	Percentage of participants with a 1-year TLR free survival	within 12 months post-procedure
Incidence of complications	Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure	immediately following procedure (day 30)
Major adverse event	Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality	within 12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Technical success, defined as the ability to cross the target lesion with the device, set up antegrade blood flow and leave residual stenosis <30%	within 24 hours post-procedure
Incidence of dissection and types	Dissection patterns according to the National Heart, Lung and Blood Institute classification system for the coronary artery. (Type A-F) (A) Type A has minor radiolucent areas, (B) type B is a linear dissection, (C) type C has contrast outside the lumen, (D) type D is a spiral dissection, (E) type E has persistent filling defects, and (F) type F is a total occlusion without distal antegrade flow	immediately following vessel preparation
Incidence of Bailout stenting	Bailout stenting, defined as stent implantation after vessel preparation and DCB including bare metal stents (BMS), covered stents and drug-eluting stents (DES)	immediately following vessel preparation and DCB angioplasty
Amputation Free Survival	Percentage of participants with a 1-year amputation free survival	within 12 months post-procedure
Numbers of patients with Primary patency	Primary patency rate at 6, 12, 24 months as determined by Duplex ultrasound at six months, defined as a target vessel with <50% diameter stenosis (systolic velocity ratio no greater than 2.4), without occurrence of target lesion revascularization between the index procedure and follow-up control	within 3, 6, 12 months post-procedure
Improvement of ABI	Increase of Ankle-Brachial Index (ABI) at 12, 24 months, defined as: an increase in ABI compared to baseline	within 3, 6, 12 months post-procedure
Improvement of related symptoms	related symptoms could be identified as Rutherford classification from level 1-6. improvement in Rutherford classification compared to the pre-procedure Rutherford classification	within 3, 6, 12 months post-procedure

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital
• Collaborators: Shanghai Zhongshan Hospital; RenJi Hospital; Huashan Hospital; Xuanwu Hospital, Beijing; First Affiliated Hospital of Zhejiang University; Second Affiliated Hospital of Soochow University; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Qingdao Hiser Medical Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ANTICIPATED): May 31, 2024
• Study Completion (ANTICIPATED): May 31, 2024

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (ACTUAL): July 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: drug-coated balloon; debulking; endovascular therapy; femoropopliteal Artery Occlusion; bail-out stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: Shanghai-CIVILIAN

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