Clinical trial NCT05616520: Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon
Official title: Clinical Efficacy for the Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon：a Real-world Registry Study(CARPLAY-DCB Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Keywords: drug-coated balloon
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Tianjin Medical University General Hospital
name: Second Affiliated Hospital of Suzhou University
name: Fudan University
name: RenJi Hospital
name: The Affiliated Hospital of Qingdao University
name: First Affiliated Hospital of Zhejiang University
name: Chengdu University of Traditional Chinese Medicine
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Huashan Hospital
First posted: 2022-11-15
Enrollment: 838
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with complex femoralpopliteal artery lesions.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from clinically-driven target lesion revascularization(CD-TLR)
timeFrame: 24 months
Secondary outcomes:
measure: Primary patency
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
measure: Freedom from clinically-driven target lesion revascularization(CD-TLR)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
measure: Major adverse events
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
measure: Technical success rate
timeFrame: 1 week
measure: Rutherford classification change
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
measure: improvement of EQ-5D-5L
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
measure: improvement of Vas-QoL
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References:
citation: Laird JA, Schneider PA, Jaff MR, Brodmann M, Zeller T, Metzger DC, Krishnan P, Scheinert D, Micari A, Wang H, Masters M, Tepe G. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019 Jun;12(6):e007702. doi: 10.1161/CIRCINTERVENTIONS.118.007702. Epub 2019 Jun 14.
citation: Soga Y, Iida O, Fujihara M, Kawasaki D, Saito S, Urasawa K, Yokoi H, Fernandez EJ, Guo J, Nakamura M; IN.PACT Japan Post-Market Surveillance Study. Real-World Clinical Outcomes of IN.PACT Admiral Drug-Coated Balloon for Femoropopliteal Artery Disease - 12-Month Results From Japan Post-Market Surveillance Study. Circ J. 2021 Nov 25;85(12):2149-2156. doi: 10.1253/circj.CJ-21-0491. Epub 2021 Oct 6.