Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Other: SBCV; Other: Saline

• Registration Number: NCT02568293
• Lead Sponsor: Symic Vascular

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09
• Primary Completion: 2017-09
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBCV	SBCV	SBCV is administered to the site immediately post balloon dilation.
Control	Saline	Saline is used as a control and is delivered immediately post balloon dilation.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Royal Prince Alfred Hospital; 🇦🇺 Melbourne, New South Wales, Australia

Gold Coast University Hospital; 🇦🇺 Southport, Queensland, Australia

Austin Health; 🇦🇺 Heidelberg, Victoria, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

Flinders Medical Center; 🇦🇺 Adelaide, South Australia, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Western Australia, Australia