MedDataX Logo

Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease

NCT ID: NCT03380650

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency rate after stent implantation. The chronic inflammation induced by stenting could be a main reason of re-stenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices, such as paclitaxel-coated balloon dilation, directional atherectomy, are developed. Directional atherectomy can effectively remove the atherosclerosis plaque but leave the inflammatory reaction along the atherectomy route. Here, we propose the hypothesis that using local drug delivery with balloon system can relieve the inflammation induced by atherectomy. Therefore, 40 patients of femoropopliteal occlusive disease will be randomly allocated into the group "directional atherectomy+local drug delivery with balloon system" or "drug-coated balloon only". The 1-year patency rate, incidence of complications, imaging parameters will be compared between groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Artery Disease Endovascular Treatment

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

femoropopliteal occlusive disease directional atherectomy local drug delivery endovascular treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
only the doctor know the group the patient goes into

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

durg-coated balloon dilation

The drug-coated balloon will be used to treat the femoropopliteal occlusion.

Group Type OTHER

drug-coated balloon dilation

Intervention Type DEVICE

use of drug-coated balloon dilation for the treatment of femoralpopliteal disease

directional atherectomy and LDD

The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion.

Group Type OTHER

directional atherectomy and locol drug delivery

Intervention Type DEVICE

combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

directional atherectomy and locol drug delivery

combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease

Intervention Type DEVICE

drug-coated balloon dilation

use of drug-coated balloon dilation for the treatment of femoralpopliteal disease

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age of 18-80 years old
* patients of femoropopliteal occlusive disease (Rutherford 2-4)
* length of lesion ≤ 20cm
* have signed the informed consent

Exclusion Criteria

* serum Cr \> 150 umol/L
* patients with acute thrombosis
* received endovascular treatment for femoropopliteal disease in recent 6 months
* less than 1 run-off vessel
* allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
* pregnancy and lactation
* relatively easy bleeding
* malignancy or irreversible organ failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lan Zhang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shuofei Yang, M.D., Ph.D.

Role: CONTACT

Phone: +86 13764227372

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-092

Identifier Type: -

Identifier Source: org_study_id