NCT02568293

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

October 1, 2015

Last Update Submit

February 8, 2017

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

SBCV

EXPERIMENTAL

SBCV is administered to the site immediately post balloon dilation.

Other: SBCV

Control

PLACEBO COMPARATOR

Saline is used as a control and is delivered immediately post balloon dilation.

Other: Saline

Interventions

SBCVOTHER

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

SBCV
SalineOTHER

Saline is used as a control.

Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Royal Prince Alfred Hospital

Melbourne, New South Wales, 2050, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Flinders Medical Center

Adelaide, South Australia, 5043, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 5, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

NZ(1)AU(7)