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

This study is currently recruiting participants.

See

Contacts and Locations

Verified September 2015 by Leonardo Bolognese, MD, Ospedale San Donato

Sponsor:

Information provided by (Responsible Party):

Leonardo Bolognese, MD, Ospedale San Donato

ClinicalTrials.gov Identifier:

NCT02563535

First received: September 27, 2015

Last updated: September 28, 2015

Last verified: September 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Peripheral Artery Disease	Device: DEB Device: PTA	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Further study details as provided by Leonardo Bolognese, MD, Ospedale San Donato:

Primary Outcome Measures:

Late Lumen Loss (LLL) in the target lesion documented by angiography [ Time Frame: 6 months ]
Late Lumen Loss (LLL) in the target lesion documented by angiography

Secondary Outcome Measures:

Number of events of angiographic binary restenosis [ Time Frame: 12 months ]
number of events of angiographic binary restenosis
Number of events of target lesion revascularization (TLR) [ Time Frame: 12 months ]
number of events of target lesion revascularization


Estimated Enrollment:	140
Study Start Date:	September 2015
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Drug-eluting balloon angioplasty with Litos drug-eluting balloon	Device: DEB angioplasty with Litos drug eluting balloon
Active Comparator: conventional PTA angioplasty with conventional balloon	Device: PTA angioplasty with conventional balloon

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02563535

Locations


Italy
Cardiovascular Department, Ospedale S.Donato	Recruiting
Arezzo, AR, Italy, 52100
Contact: Francesco Liistro, MD francescoliistro@hotmail.com
Principal Investigator: Leonardo Bolognese, MD, FESC
Sub-Investigator: Giovanni Falsini, MD
Sub-Investigator: Paolo Angioli, MD
Sub-Investigator: Kenneth Ducci, MD
Principal Investigator: Francesco Liistro, MD
Sub-Investigator: Simone Grotti, MD

Sponsors and Collaborators

Ospedale San Donato

More Information


Responsible Party:	Leonardo Bolognese, MD, MD, Ospedale San Donato
ClinicalTrials.gov Identifier:	NCT02563535 History of Changes
Other Study ID Numbers:	Arezzo015
Study First Received:	September 27, 2015
Last Updated:	September 28, 2015

Additional relevant MeSH terms:


Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases	Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 11, 2017

To Top