NCT02563535

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

September 27, 2015

Last Update Submit

January 17, 2020

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Number of events of angiographic occlusive restenosis

    6 months

  • Number of events of target lesion revascularization (TLR)

    12 months

Study Arms (2)

Drug-eluting balloon

EXPERIMENTAL

angioplasty with Litos drug-eluting balloon

Device: DEB

conventional PTA

ACTIVE COMPARATOR

angioplasty with conventional balloon

Device: PTA

Interventions

DEBDEVICE

angioplasty with Litos drug eluting balloon

Drug-eluting balloon
PTADEVICE

angioplasty with conventional balloon

conventional PTA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 27, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

IT(1)