Clinical trial NCT04826705: A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon
Official title: A Prospective, Multicenter, Observational Study of Short and Long-term Outcome in Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon (PROMISING Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Drug-coated Balloon
Femoropopliteal Artery Occlusion
Angioplasty
Lead sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Zhejiang University
name: Xuanwu Hospital, Beijing
name: First People's Hospital of Hangzhou
name: Second Affiliated Hospital of Suzhou University
name: Qingdao University
name: Chengdu University of Traditional Chinese Medicine
First posted: 2021-04-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with femoralpopliteal artery occlusion.

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.

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. 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.

Eligibility criteria: Inclusion Criteria:

1. Rutherford grade 2-5.
2. 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.
3. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
4. The guide wire needs to pass through the lesion.
5. Life expectancy\> 24 months.
6. 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.
7. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
8. There is at least one continuous infrapopliteal outflow artery or obtained through intravascular reconstruction.
9. For combined aortic iliac artery disease, the blood flow can be recanalized after intravascular reconstruction without residual stenosis exceeding 50%.

Exclusion Criteria:

1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction 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 devices that 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 Berg's disease.
7. Patients who have undergone arterial bypass on the treatment side.

Primary outcomes:
measure: Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 48 months
measure: Major adverse events
timeFrame: 48 months
Secondary outcomes:
measure: Changes of the patency rate of target lesions at post-interventional
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
measure: Technical success rate
timeFrame: 1 week
measure: Vascular quality of life questionnaire(VascuQol)
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
measure: The patient's ulcer healing
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
measure: Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
measure: Major adverse events
timeFrame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zibo Feng
state: Hubei
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chengdu
country: China
facility: Hospital of Chengdu University of Traditional Chinese Medicine
city: Hangzhou
country: China
facility: Hangzhou First People's hospital of Medical College of Zhejiang University
city: Hangzhou
country: China
facility: the First Affiliated hospital of Medicine College of Zhejiang University
city: Qingdao
country: China
facility: Qingdao Haici hospital affiliated to Qingdao University
city: Shanghai
country: China
facility: Renji Hospital of Shanghai Jiaotong University
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
city: Suzhou
country: China
facility: the second Affiliated Hospital of Medical College of Suzhou University
Study officials:
affiliation: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Zibo Feng
role: PRINCIPAL_INVESTIGATOR
References: