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

Last updated: October 18, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Claudication

Circulation Disorders

Treatment

drug-coated balloon

Clinical Study ID

NCT05616520
CARPLAY-DCB Study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Rutherford grade 2-5.
  2. Femoropopliteal artery disease (stenosis > 50%) with at least one of following complexlesion characteristics: - long lesion (>150 mm), CTO(>50 mm),in-stentrestenosis(Tosaka Ⅱ、Ⅲ), calcified lesion (PACCS grade 2-4)
  3. Patients who understand the purpose of this study, volunteer to participate in theexperiment, 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 inthe group according to the intracavitary treatment time.
  8. There is at least one continuous below-the-knee outflow artery or obtained byendovascular reconstruction.
  9. For patients combined aortic iliac artery disease, the inflow can be recanalized afterendovascular reconstruction without illiac residual stenosis exceeding 50%.

Exclusion

Exclusion Criteria:

  1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardialinfarction 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 devicesthat 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

Total Participants: 838
Treatment Group(s): 1
Primary Treatment: drug-coated balloon
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100053
    China

    Active - Recruiting

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