A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon

Angioplasty Clinical Trial

— PROMISING  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04826705
• Other study ID #: the PROMISING Study
• Status: Active, not recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2027

Study information

• Verified date: December 2023
• Source: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angioplasty
• Drug-coated Balloon
• Femoropopliteal Artery Occlusion

Intervention

Device:
• Drug-coated Balloon
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.

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing
China	Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu
China	Hangzhou First People's hospital of Medical College of Zhejiang University	Hangzhou
China	the First Affiliated hospital of Medicine College of Zhejiang University	Hangzhou
China	Qingdao Haici hospital affiliated to Qingdao University	Qingdao
China	Renji Hospital of Shanghai Jiaotong University	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai
China	the second Affiliated Hospital of Medical College of Suzhou University	Suzhou
China	Zibo Feng	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology	Chengdu University of Traditional Chinese Medicine, First People's Hospital of Hangzhou, Qingdao University, RenJi Hospital, Second Affiliated Hospital of Suzhou University, Xuanwu Hospital, Beijing, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Major adverse events	Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.	48 months
Secondary	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
Secondary	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.	1 week
Secondary	Vascular quality of life questionnaire(VascuQol)	The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Secondary	The patient's ulcer healing	Ulcer healing in patients with Rutherford grade 5	1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Secondary	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.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Secondary	Major adverse events	Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.	1 month, 3 months, 6 months, 12 months, 24 months, 36 months