DCB Compared Stenting in Popliteal Lesions

NCT03739580 | Unknown FDA Device

• 1 other identifier: DBSP-XWHCMU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Popliteal Stenosis; Popliteal Artery Occlusion; Diabetes

Keywords

drug-coating balloon; stent; popliteal artery; atherosclerotic occlusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Rutherford classification

  12 months

• ABI

  12 months

• TcpO2

  12 months

• Wagnar classification

  12 months

• Target vessel revascularization rate

  12 months

Study Arms (2)

drug-coating balloon

EXPERIMENTAL

drug-coating balloon (Orchid) intervention

Device: DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)

stent deployment

ACTIVE COMPARATOR

metal bare stent intervention

Device: Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)

Interventions

DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.) DEVICE

for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.

drug-coating balloon

Stent (Maris,Medtronic.USA or Sinus/Supera, Germany) DEVICE

for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.

stent deployment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Gu Yong Quan

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Stents

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Yongquan Gu, M.D.

  Xuanwu hospital CMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianming Guo, M.D.

CONTACT

+86 1314-636-9562; guojianming@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, vascular suregry department

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 14, 2018
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: September 1, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (1)