DCB Compared Stenting in Popliteal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-09-01

Brief Summary

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

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Detailed Description

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Conditions

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Popliteal Stenosis Popliteal Artery Occlusion Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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drug-coating balloon

drug-coating balloon (Orchid) intervention

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

stent deployment

metal bare stent intervention

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No