A Study of Endovascular Treatment of Femoropopliteal Arte... | NCT04826705

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Feb 1, 2025Estimated

Completion Date

Feb 1, 2027Estimated

First Submitted Date

Mar 29, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2024

Last Update Posted Date

Mar 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zibo Feng, Director of Vascular Surgery, Liyuan Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
RenJi Hospital	OTHER
Zhejiang University	OTHER
Xuanwu Hospital, Beijing	OTHER
First People's Hospital of Hangzhou

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.

Detailed Description

Traditional endovascular approaches to the treatment of atherosclerotic disease in the femoropopliteal arteries include percutaneous transluminal angioplasty (PTA) with an uncoated balloon and implantation of a bare metal stent. Recently, drug-eluting stents (DES) and drug-coated balloons (DCB) that transfer paclitaxel to the vessel wall during revascularization have been added to the suite of tools available to interventionists, helping to prevent restenosis after treatment.

Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB. It is estimated that 1200 patients with chronic femoral popliteal artery occlusion were enrolled in the group at 8 centers in China in two years. The follow-up would be conducted at 1, 3, 6, 12, 18, 24, 36 and 48 months after the operation to assess the efficacy and safety of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Name	Type	Description	Arm Group Labels	Other Names
Drug-coated Balloon	Device	To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional	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.	48 months
Major adverse events	Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.	48 months

Secondary Outcomes

Measure	Description	Time Frame
Changes of the patency rate of target lesions at post-interventional	The patency rate of target(Femoropopliteal) lesions would be determined by vascular ultrasound,Restenosis would be diagnosed if the peak systolic velocity ratio(PSVR)≥2. 5.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rutherford grade 2-5.
Femoral popliteal artery stenosis or occlusion, a clear outflow tract no less than 10cm long at the distal end of the knee should be continuous with a clear outflow tract under the ankle.
Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
The guide wire needs to pass through the lesion.
Life expectancy> 24 months.
Patients with thrombosis of the lower extremities, patients who received drug-coated balloon (DCB) intervention after thrombus removal through mechanical thrombus removal, percutaneous catheter thrombolysis, and thrombus removal.
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 infrapopliteal outflow artery or obtained through intravascular reconstruction.
For combined aortic iliac artery disease, the blood flow can be recanalized after intravascular reconstruction without residual stenosis exceeding 50%.

Exclusion Criteria:

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 Berg's disease.
Patients who have undergone arterial bypass on the treatment side.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with femoralpopliteal artery occlusion.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Zibo Feng	Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Zibo Feng		Wuhan	Hubei	430000	China
Xuanwu Hospital Capital Medical University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42420851	Derived	Li C, Zhu Y, Yang W, Du Y, Song Q, Wang T, Wang X, Li L, Feng Z. Impact of below-the-knee runoff in patients undergoing drug-coated balloon angioplasty for femoropopliteal disease: a propensity score-matched analysis. BMC Cardiovasc Disord. 2026 Jul 8. doi: 10.1186/s12872-026-06193-x. Online ahead of print.