Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis (SHIELD)

Symic Vascular

Status

Unknown

Conditions

Peripheral Arterial Disease

Treatments

Other: Saline

Other: SBCV

Study type

Interventional

Funder types

Industry

Identifiers

NCT02568293

TP-1601

Details and patient eligibility

About

The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.

Full description

This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.

Enrollment

66 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s)
Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)
Lesions are ≥70% stenosis by visual estimate
A patent inflow artery free from significant lesion
At least one patent native outflow artery to the ankle

Exclusion criteria

History of haemorrhagic stroke within 3 months of screening
History of myocardial infarction, thrombolysis or angina within 2 weeks of screening
Renal failure or chronic kidney disease
Severe calcification that renders the lesion undilatable