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

Clinical Efficacy for the Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon：a Real-world Registry Study(CARPLAY-DCB Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Estimated): 838

Contacts and Locations

• Study Contact: Name: Lianrui Guo, MD.; Phone Number: 86-13671009746; Email: guolianrui@xwhosp.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Liqiang Li, MD; Phone Number: 18618286609; Email: liliqiang@xwhosp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with complex femoralpopliteal artery lesions.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from clinically-driven target lesion revascularization(CD-TLR)	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	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.	1 week
Primary patency	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	1 month, 3 months, 6 months, 12 months, 24 months
Freedom from clinically-driven target lesion revascularization(CD-TLR)	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.	1 month, 3 months, 6 months, 12 months, 24 months
Major adverse events	Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.	1 month, 3 months, 6 months, 12 months, 24 months
Rutherford classification change	Rutherford classification change including ulcer healing in patients with Rutherford grade 5	1 month, 3 months, 6 months, 12 months, 24 months
improvement of EQ-5D-5L	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.	1 month, 3 months, 6 months, 12 months, 24 months
improvement of Vas-QoL	Improvement in the quality of life scores (Vas-QoL) at 1 month, 3 months, 6 months, 12 months, 24 months after surgery.	1 month, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Changhai Hospital; Fudan University; RenJi Hospital; Huashan Hospital; Chengdu University of Traditional Chinese Medicine; The Affiliated Hospital of Qingdao University; First Affiliated Hospital of Zhejiang University; Tianjin Medical University General Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Second Affiliated Hospital of Suzhou University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: drug-coated balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CARPLAY-DCB Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No