Clinical trial NCT05473884: Lesion Preparation in Femoropopliteal Artery Occlusion Disease
Official title: CIVILIAN Study in Femoropopliteal Artery Occlusion Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoropopliteal Artery Occlusion
Atherosclerosis Obliterans
Lesion; Vascular
In-stent Restenosis
Keywords: femoropopliteal Artery Occlusion
debulking
drug-coated balloon
bail-out stenting
endovascular therapy
Lead sponsor: Shanghai Pudong Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanghai Zhongshan Hospital
name: Huashan Hospital
name: First Affiliated Hospital of Zhejiang University
name: Xuanwu Hospital, Beijing
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Second Affiliated Hospital of Soochow University
name: Qingdao Hiser Medical Group
First posted: 2022-07-26
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from TLR
timeFrame: within 12 months post-procedure
measure: Incidence of complications
timeFrame: immediately following procedure (day 30)
measure: Major adverse event
timeFrame: within 12 months post-procedure
Secondary outcomes:
measure: Technical Success
timeFrame: within 24 hours post-procedure
measure: Incidence of dissection and types
timeFrame: immediately following vessel preparation
measure: Incidence of Bailout stenting
timeFrame: immediately following vessel preparation and DCB angioplasty
measure: Amputation Free Survival
timeFrame: within 12 months post-procedure
measure: Numbers of patients with Primary patency
timeFrame: within 3, 6, 12 months post-procedure
measure: Improvement of ABI
timeFrame: within 3, 6, 12 months post-procedure
measure: Improvement of related symptoms
timeFrame: within 3, 6, 12 months post-procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
Study officials:
References: