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

NCT01969630 | Unknown Phase 4

• 1 other identifier: Arezzo011
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Artery Disease

Keywords

femoropopliteal lesions

Outcome Measures

Primary Outcomes (1)

• angiographic binary restenosis

  incidence of binary restenosis

  12 months

Secondary Outcomes (1)

• Composite of all cause mortality, major amputation and target lesion revascularization.

  12 months

Study Arms (2)

PEB

ACTIVE COMPARATOR

PEB angioplasty plus provisional nitinol stent implantation

Device: PEB

PES

EXPERIMENTAL

Systematic PES angioplasty

Device: PES

Interventions

PEB DEVICE

Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation

PEB

PES DEVICE

Systematic Paclitaxel eluting stent angioplasty

PES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Donato: lead

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 31296293 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral 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: Director

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

IT (1)