Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01969630

Recruitment Status : Unknown

Verified October 2013 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was: Recruiting

First Posted : October 25, 2013

Last Update Posted : October 25, 2013

Sponsor:

Information provided by (Responsible Party):

Leonardo Bolognese, MD, Ospedale San Donato

Study Description

Brief Summary:

To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

Condition or disease	Intervention/treatment	Phase
Peripheral Artery Disease	Device: PEB Device: PES	Phase 4

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	October 2013
Estimated Primary Completion Date :	October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PEB PEB angioplasty plus provisional nitinol stent implantation	Device: PEB Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
Experimental: PES Systematic PES angioplasty	Device: PES Systematic Paclitaxel eluting stent angioplasty

Outcome Measures

Primary Outcome Measures :

angiographic binary restenosis [ Time Frame: 12 months ]
incidence of binary restenosis

Secondary Outcome Measures :

Composite of all cause mortality, major amputation and target lesion revascularization. [ Time Frame: 12 months ]
incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

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

Criteria

Inclusion Criteria:

intermittent claudication or critical limb ischemia
de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries
presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk
presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis >70%)

Exclusion Criteria:

life expectancy <1 year
contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel
need for major amputation (MA) at the time of enrolment
Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969630

Locations

Layout table for location information

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
Sub-Investigator: Italo Porto, MD

Sponsors and Collaborators

Ospedale San Donato

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liistro F, Angioli P, Porto I, Ducci K, Falsini G, Ventoruzzo G, Ricci L, Scatena A, Grotti S, Bolognese L. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. doi: 10.1016/j.jacc.2019.04.057.

Layout table for additonal information

Responsible Party:	Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier:	NCT01969630 History of Changes
Other Study ID Numbers:	Arezzo011
First Posted:	October 25, 2013 Key Record Dates
Last Update Posted:	October 25, 2013
Last Verified:	October 2013

Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:


femoropopliteal lesions

Additional relevant MeSH terms:

Layout table for MeSH terms

Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases Paclitaxel	Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

To Top