Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiovascular Diseases Intermittent Claudication Peripheral Arterial Disease Vascular Diseases

Keywords

Peripheral Arterial DiseaseIntermittent ClaudicationVascular DiseasesCardiovascular DiseasesSuperficial Femoral Artery

Outcome Measures

Primary Outcomes (2)

Patency by Ultrasound
Patency measured by duplex ultrasound with ≤50% restenosis (Peak Systolic Velocity Ratio (PSVR ≤ 2.4).
through 6 months
Major Adverse Events
Freedom from all causes of death, emergent endovascular intervention or surgical intervention on the target limb, index limb amputation.
30 days

Secondary Outcomes (7)

Clinical Success
48 hours

Study Arms (1)

STANZA Drug-eluting Resorbable Scaffold

EXPERIMENTAL

Treatment of Superficial Femoral Artery (SFA) lesion with resorbable scaffold

Device: STANZA Drug-eluting resorbable Scaffold

Interventions

STANZA Drug-eluting resorbable ScaffoldDevice

Also known as: Paclitaxel-eluting resorbable scaffold

STANZA Drug-eluting Resorbable Scaffold

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age \> 18 years.
De novo stenotic lesion(s) in the superficial femoral artery located at least 1 cm distal to the femoral bifurcation and \> 5 cm above the joint space of the knee.

Sponsors & Collaborators

480 Biomedical
Industrylead

Study Sites (9)

Universitäts Klinikum Graz

Graz, Austria

WGKK - Hanusch-Krankenhaus

Vienna, 1140, Austria

Cardiovascular and Interventional Radiology- AKH

Vienna, Austria

Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, 83022, Germany

Universitätsklinikum Leipzig AöR

Leipzig, Saxony, 04103, Germany

Auckland City Hospital

Auckland, New Zealand

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent ClaudicationVascular DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Andrew Holden, MD
Auckland City Hospital
PRINCIPAL INVESTIGATOR

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

October 2013

Date type not reported

This date has not been verified as actual or estimated.

Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

STANZA Drug-eluting Resorbable Scaffold

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

STANZA Drug-eluting Resorbable Scaffold

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations