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
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Artery Disease | Device: PEB Device: PES | Phase 4 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: PEB
PEB angioplasty plus provisional nitinol stent implantation
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Device: PEB
Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation |
Experimental: PES
Systematic PES angioplasty
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Device: PES
Systematic Paclitaxel eluting stent angioplasty |
- angiographic binary restenosis [ Time Frame: 12 months ]incidence of binary restenosis
- 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.

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

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
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 |
Responsible Party: | Leonardo Bolognese, MD, Director, Ospedale San Donato |
ClinicalTrials.gov Identifier: | NCT01969630 |
Other Study ID Numbers: |
Arezzo011 |
First Posted: | October 25, 2013 Key Record Dates |
Last Update Posted: | October 25, 2013 |
Last Verified: | October 2013 |
femoropopliteal lesions |
Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases |