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

NCT05616520 | Unknown DMC

• 1 other identifier: CARPLAY-DCB Study
• Study Type: observational
• Target: 838
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Primary patency

  1 month, 3 months, 6 months, 12 months, 24 months

• Freedom from clinically-driven target lesion revascularization(CD-TLR)

  1 month, 3 months, 6 months, 12 months, 24 months

• Major adverse events

  1 month, 3 months, 6 months, 12 months, 24 months

• Technical success rate

  1 week

• Rutherford classification change

  1 month, 3 months, 6 months, 12 months, 24 months

Interventions

drug-coated balloon DEVICE

The intervention relates to a drug-coated balloon catheter includes a balloon and cover the drug-coated balloon surface.

Eligibility Criteria

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

Study Population

Patients with complex femoralpopliteal artery lesions.

You may qualify if:

• Rutherford grade 2-5.
• 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)
• Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
• The guidewire needs to pass through the lesion.
• Life expectancy\> 24 months.
• Patients who received DCB intervention after thrombus removal through PMT or CDT.
• Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
• There is at least one continuous below-the-knee outflow artery or obtained by endovascular reconstruction.
• For patients combined aortic iliac artery disease, the inflow can be recanalized after endovascular reconstruction without illiac residual stenosis exceeding 50%.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 31195825 BACKGROUND

• 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.

  PMID: 34615815 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Lianrui Guo, MD.

CONTACT

86-13671009746; guolianrui@xwhosp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: November 15, 2022
• Study Start: June 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-06

Locations

CN (1)