Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

Peripheral Arterial Disease Clinical Trial

— SHIELD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02568293
• Other study ID #: TP-1601
• Status: Active, not recruiting
• Phase: N/A
• First received: October 1, 2015
• Last updated: February 8, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: February 2017
• Source: Symic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• SBCV
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
• Saline
Saline is used as a control.

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Adelaide	South Australia
Australia	Austin Health	Heidelberg	Victoria
Australia	Royal Prince Alfred Hospital	Melbourne	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	Royal North Shore Hospital	Sydney	New South Wales
New Zealand	Auckland City Hospital	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Symic Vascular	Symic Biomedical, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	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	through 24 weeks
Primary	Late Lumen Loss	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.	24 weeks