Lesion Preparation in Femoropopliteal Artery Occlusion Disease

NCT05473884 | Unknown DMC

• 1 other identifier: Shanghai-CIVILIAN
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoropopliteal Artery Occlusion; Atherosclerosis Obliterans; Lesion; Vascular; In-stent Restenosis

Keywords

femoropopliteal Artery Occlusion; debulking; drug-coated balloon; bail-out stenting; endovascular therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Technical Success

  within 24 hours post-procedure

• Incidence of dissection and types

  immediately following vessel preparation

• Incidence of Bailout stenting

  immediately following vessel preparation and DCB angioplasty

• Amputation Free Survival

  within 12 months post-procedure

• Numbers of patients with Primary patency

  within 3, 6, 12 months post-procedure

Study Arms (2)

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

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

Interventions

lesion preparation devices DEVICE

successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty

Also known as: Chocolate balloon, Shockwave balloon, Rotarex, TurboHawk, Jetstream

lesion preparation with debulking devices in femoropopliteal Artery occlusion

conventional balloon DEVICE

Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.

lesion preparation with POBA in femoropopliteal Artery occlusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201200, China

RECRUITING

Central Study Contacts

Bo Yu, M.D.

CONTACT

18918922698; paul.yubo@gmail.com

Weihao Shi, M.D.

CONTACT

13601982603; vascular741021@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 26, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)