Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions
NCT ID: NCT03129750
Last Updated: 2017-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-08-31
2020-09-30
Brief Summary
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The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently available on the market.
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Detailed Description
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The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.
Patients elected for endovascular revascularization with DCB will be asked their written consent to the use of their personal data.
Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days), 24 and 36 months (±30 days). Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Drug Coated Balloon
Peripheral PTA with a drug coated balloon
Eligibility Criteria
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Inclusion Criteria
2. Target lesion consists of a single solitary or multiple adjacent de novo or re-stenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm
3. Target vessel is the superficial femoral artery and/or popliteal artery (P1-2-3)
4. Life expectancy \>1 year in the Investigator's opinion
5. Written informed consent
Exclusion Criteria
2. Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure
3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
4. Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure
5. ≥15 cm long inflow lesion (≥50% DS)
6. Failure to successfully treat \< 15 cm long inflow lesion in the ipsilateral Iliac artery
18 Years
ALL
No
Sponsors
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Ettore Sansavini Health Science Foundation
OTHER
Responsible Party
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Principal Investigators
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Antonio Micari, MD
Role: PRINCIPAL_INVESTIGATOR
Maria Cecilia Hospital
Locations
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Casa di Cura Montevergine
Mercogliano, Avellino, Italy
ICLAS
Rapallo, Genova, Italy
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
Santa Maria Hospital
Bari, , Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, , Italy
Città di Lecce Hospital
Lecce, , Italy
Policlinico Federico II
Napoli, , Italy
Maria Eleonora Hospital
Palermo, , Italy
Azienda Policlinico Umberto I di Roma
Roma, , Italy
Maria Pia Hospital
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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Angelo Cioppa, MD
Role: primary
Antonio Micari, MD
Role: primary
Giuseppe Roscitano, MD
Role: primary
Pierfrancesco Veroux, MD, PhD
Role: primary
Armando Liso, MD
Role: primary
Giovanni Esposito, MD, PhD
Role: primary
Giuseppe Vadalà, MD
Role: primary
Fabrizio Fanelli, MD
Role: primary
Other Identifiers
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ESREFO26
Identifier Type: -
Identifier Source: org_study_id
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