Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05616520
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population. This data collection aims to perform regularly clinical follow up to guide the standardized diagnosis and treatment of patients post-operatively, in order to achieve the maximum clinical benefits of these patients, as well as improve the development of the field of peripheral artery disease treated by drug-coated balloon.

Detailed Description

Historically, symptomatic PAD was treated with surgical bypass; however endovascular treatment is now the first line treatment when medical therapy fails. Several endovascular treatment options exist including percutaneous transluminal angioplasty (PTA), stenting with bare metal or drug-eluting stents (DES), cutting balloons, atherectomy, laser debulking. Moreover, drug-coated balloon（DCB）has emerged as a potential treatment option, combining acute restoration of vessel patency by balloon dilatation with long term maintenance of such patency by the anti-proliferative drug delivered by the balloon surface. Results from numerous clinical studies with paclitaxel coated balloons have been reported for the safety and efficacy for peripheral artery diseases.

Besides Medtronic IN.PACT Admiral, other DCBs approved for marketing in Chinese Mainland include Acoart (Acotec, China), Reewarm ® PTX (endovastec, China), Ultrafree (ZYLOX, China). Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population. Therefore, the data collection can also further expand and understand the experience of using DCB in a real world patient population in China, especially for the surveillance of safety events, in order to ensure the long-term application safety in Chinese population. Moreover, this data collection aims to perform regularly clinical follow up to guide the standardized diagnosis and treatment of patients post-operatively, in order to achieve the maximum clinical benefits of these patients, as well as improve the development of the field of peripheral artery disease treated by drug-coated balloon.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-11-13
• Study First Posted: 2022-11-15
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 838

Inclusion Criteria

1. Rutherford grade 2-5.
2. Femoropopliteal artery disease (stenosis > 50%) with at least one of following complex lesion characteristics: - long lesion (>150 mm), CTO(>50 mm),in-stent restenosis(Tosaka Ⅱ、Ⅲ), calcified lesion (PACCS grade 2-4)
3. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
4. The guidewire needs to pass through the lesion.
5. Life expectancy> 24 months.
6. Patients who received DCB intervention after thrombus removal through PMT or CDT.
7. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
8. There is at least one continuous below-the-knee outflow artery or obtained by endovascular reconstruction.
9. For patients combined aortic iliac artery disease, the inflow can be recanalized after endovascular reconstruction without illiac residual stenosis exceeding 50%.

Exclusion Criteria

1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
2. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
3. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
4. Pregnant and lactating women.
5. Patients who are unable or unwilling to participate in this trial.
6. Patients with Buerger's disease.
7. Patients who have undergone arterial bypass on the treatment side.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from clinically-driven target lesion revascularization(CD-TLR)	24 months	Primary patency is defined as freedom from clinically driven TLR and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4

Secondary Outcome Measures

Name	Time	Method
improvement of Vas-QoL	1 month, 3 months, 6 months, 12 months, 24 months	Improvement in the quality of life scores (Vas-QoL) at 1 month, 3 months, 6 months, 12 months, 24 months after surgery.
improvement of EQ-5D-5L	1 month, 3 months, 6 months, 12 months, 24 months	Improvement in the European Five Dimensional Health Scale (EQ-5D-5L) at 1 month, 3 months, 6 months, 12 months, and 24 months after surgery.
Primary patency	1 month, 3 months, 6 months, 12 months, 24 months	Primary patency is defined as freedom from clinically driven TLR and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4
Technical success rate	1 week	Successfully revascularize the target vessel. The residual stenosis is \<30% and there is no acute thrombosis occurred in the target vessel within 1 week post-operation.
Freedom from clinically-driven target lesion revascularization(CD-TLR)	1 month, 3 months, 6 months, 12 months, 24 months	Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure baseline.
Major adverse events	1 month, 3 months, 6 months, 12 months, 24 months	Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.
Rutherford classification change	1 month, 3 months, 6 months, 12 months, 24 months	Rutherford classification change including ulcer healing in patients with Rutherford grade 5

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China