Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02568293

Acronym

SHIELD

Enrollment

Registered

2015-10-05

Start date

2015-10-31

Completion date

2017-10-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief summary

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

Detailed 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.

Interventions

OTHERSBCV

SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.

OTHERSaline

Saline is used as a control.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events	through 24 weeks	The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment: * Index limb amputation (above or below the ankle) * Index limb re-intervention * Index-limb-related death
Late Lumen Loss	24 weeks	LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026