AzTrials
AzTrials

Peripheral Arterial DiseaseNCT05616520

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

An observational study of Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
drug-coated balloon
Type of treatment
Medical device
How many people
838 participants
Where
1 siteChina
Study dates
1 Jun 2023to 31 May 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with complex femoralpopliteal artery lesions.

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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%.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lianrui Guo, MD. contact

86-13671009746

guolianrui@xwhosp.org

China1 site, 1 recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

    Liqiang Li, MD, 18618286609, liliqiang@xwhosp.org

    Recruiting

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
drug-coated balloon
Keywords
drug-coated balloon
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • drug-coated balloonDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (7)

  1. 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

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

  2. 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.

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

  3. Major adverse events

    Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.

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

  4. 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.

    Measured: 1 week

  5. Rutherford classification change

    Rutherford classification change including ulcer healing in patients with Rutherford grade 5

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2022
  2. Study start1 Jun 2023
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
838 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616520
Sponsor's protocol ID
CARPLAY-DCB Study
Status last verified
Jun 2023
First submitted
1 Sep 2022
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 31195825

  • 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.

    PubMed 34615815

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lianrui Guo, MD. (86-13671009746, guolianrui@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from clinically-driven target lesion revascularization(CD-TLR) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05616520, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in