DCB Compared Stenting in Popliteal Lesions

Diabetes Clinical Trial

Official title:

The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03739580
• Other study ID #: DBSP-XWHCMU
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2018
• Source: Xuanwu Hospital, Beijing
• Contact: Jianming Guo, M.D.
• Phone: +86 1314-636-9562
• Email: guojianming[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Symptomatic peripheral artery disease:

• Moderate or severe claudication (Rutherford category 2 or 3)

• Critical limb ischemia (Rutherford category 4 or 5)

• Atherosclerotic popliteal artery disease (stenosis > 50%)

• Patients with signed informed consent

Exclusion Criteria:

• Acute critical limb ischemia

• Severe critical limb ischemia (Rutherford category 6)

• Involvement of SFA disease with stenosis

• Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).

• Known hypersensitivity or contraindication to any of the following medications:

heparin, aspirin, clopidogrel, or contrast agent

• Age > 80 years

• Severe hepatic dysfunction (> 3 times normal reference values)

• Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis

• LVEF < 40% or clinically overt congestive heart failure

• Pregnant women or women with potential childbearing

• Life expectancy <1 year due to comorbidity

• Previous bypass surgery or stenting for the target popliteal artery

• Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Related Conditions & MeSH terms

• Diabetes
• Popliteal Artery Occlusion
• Popliteal Stenosis

Intervention

Device:
• DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
• Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.

Locations

Country	Name	City	State
China	Gu Yong Quan	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency of claudicant patients	Claudicant patients (Rutherford C1-3), primary patency defined as PSVR(peak systolic velocity ratio) =2.4, absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months	12 months after the index procedure
Primary	Salvage limb rate (for CLI patients)	Limb Salvage is defined as the freedom from secondary major amputation	12 months after the index procedure
Secondary	Rutherford classification		12 months
Secondary	ABI	Ankle Brachial index	12 months
Secondary	TcpO2	transcutaneous oxygen pressure	12 months
Secondary	Wagnar classification	incision healing information of Rutherford C5-6 patients	12 months
Secondary	Target vessel revascularization rate	frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel	12 months
Secondary	Index Limb Ischemia at 12-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	12 months
Secondary	Major Adverse Events at 12-month Post Procedure	Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.	12 months