Clinical trial NCT03129750: Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions
Official title: Safety and Efficacy of the Drug Coated Balloon (DCB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With TASC C and D Lesions: a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PAD
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic patients with ischemic vascular disease presenting with TASC C and D.

Brief summary: The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.

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.

Detailed description: The present study is designed as a prospective, open label, observational study.

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.

Eligibility criteria: Inclusion Criteria:

1. Documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4
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:

1. Patient unwilling or unlikely to comply with FU schedule
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

Primary outcomes:
measure: Rate of primary patency
timeFrame: 12 months after percutaneous treatment
Secondary outcomes:
measure: composite of all Major Adverse Events (MAE)
timeFrame: 24 months after percutaneous treatment
measure: Incidence of Major Adverse Events (MAE)
timeFrame: 36 months after percutaneous treatment
measure: Clinical improvement as assessed by Rutherford Class changes
timeFrame: 6, 12, 24 and 36 months vs baseline
Other outcomes:
measure: Rate of instrumental restenosis
timeFrame: Post-Procedure
measure: Procedural success rate
timeFrame: end of percutaneous procedure
measure: Walking capacity and quality of life
timeFrame: 6, 12, 24 and 36 months post-procedure
measure: Rate of instrumental restenosis
timeFrame: 12, 24 and 36 months
measure: Quality of Life
timeFrame: 6, 12, 24 and 36 months post-procedure
Locations:
city: Mercogliano
country: Italy
facility: Casa di Cura Montevergine
state: Avellino
city: Rapallo
country: Italy
facility: ICLAS
state: Genova
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Bari
country: Italy
facility: Santa Maria Hospital
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
city: Lecce
country: Italy
facility: Città di Lecce Hospital
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Palermo
country: Italy
facility: Maria Eleonora Hospital
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I di Roma
city: Torino
country: Italy
facility: Maria Pia Hospital
Study officials:
affiliation: Maria Cecilia Hospital
name: Antonio Micari, MD
role: PRINCIPAL_INVESTIGATOR
References: