DCB Compared Stenting in Popliteal Lesions

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes; Popliteal Artery Occlusion; Popliteal Stenosis
• Intervention / Treatment: Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.); Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Gu Yong Quan
      • Contact: Jian ming Guo, M.D.; Phone Number: 13146369562; Email: guojianming@aliyun.com
      • Contact: Yong quan Gu, M.D.; Phone Number: 15901598209; Email: gu15901598209@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drug-coating balloon; drug-coating balloon (Orchid) intervention	Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.); for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
Active Comparator: stent deployment; metal bare stent intervention	Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany); for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Salvage limb rate (for CLI patients)	Limb Salvage is defined as the freedom from secondary major amputation	12 months after the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index Limb Ischemia at 12-month Follow up	Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.	12 months
Rutherford classification		12 months
ABI	Ankle Brachial index	12 months
TcpO2	transcutaneous oxygen pressure	12 months
Wagnar classification	incision healing information of Rutherford C5-6 patients	12 months
Target vessel revascularization rate	frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel	12 months
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Yongquan Gu, M.D., Xuanwu hospital CMU

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: stent; drug-coating balloon; popliteal artery; atherosclerotic occlusion
• Other Study ID Numbers: DBSP-XWHCMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes