Evaluation of the Use of ACOTEC Drug-Eluting Balloon Lito... | NCT02563535

Studies
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia

NCT02563535

Sponsor

Ospedale San Donato

Status

Completed

Last Update Posted

Jan 22, 2020Actual

Enrollment

105Actual

Phase

Phase 4

Conditions

Peripheral Artery Disease

Interventions

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2020Actual

Completion Date

Jan 2020Actual

First Submitted Date

Sep 27, 2015

First Submission Date that Met QC Criteria

Sep 28, 2015

First Posted Date

Sep 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2020

Last Update Posted Date

Jan 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug-eluting balloon	Experimental	angioplasty with Litos drug-eluting balloon	Device: DEB
conventional PTA	Active Comparator	angioplasty with conventional balloon	Device: PTA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DEB	Device	angioplasty with Litos drug eluting balloon	Drug-eluting balloon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Late Lumen Loss (LLL) in the target lesion documented by angiography	Late Lumen Loss (LLL) in the target lesion documented by angiography	6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of events of angiographic occlusive restenosis	number of events of angiographic occlusive restenosis	6 months
Number of events of target lesion revascularization (TLR)	number of events of target lesion revascularization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age>18 years
critical limb ischemia (Rutherford class 4-6)
angiographic stenosis>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled

Exclusion Criteria:

need for major amputation known before intervention
allergy to Paclitaxel
contraindication for combined antiplatelet treatment
life expectancy <1 year
hypersensitivity or contraindication to one of the study drugs
lack of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Department, Ospedale S.Donato		Arezzo	AR	52100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided