PAD
Conditions
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.
Interventions
DEVICEDrug Coated Balloon
Peripheral PTA with a drug coated balloon
Sponsors
Ettore Sansavini Health Science Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of primary patency | 12 months after percutaneous treatment | Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and \>50% restenosis in the treated lesion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| composite of all Major Adverse Events (MAE) | 24 months after percutaneous treatment | Incidence of the composite of all Major Adverse Events (MAE) through 24 months |
| Incidence of Major Adverse Events (MAE) | 36 months after percutaneous treatment | Incidence of Major Adverse Events (MAE) through 36 months |
| Clinical improvement as assessed by Rutherford Class changes | 6, 12, 24 and 36 months vs baseline | Clinical improvement as assessed by Rutherford Class changes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of instrumental restenosis | Post-Procedure | Rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) \> 2 post-index procedure evaluated by an independent core lab |
| Procedural success rate | end of percutaneous procedure | Rate of procedural success in the absence of peri-procedural complications |
| Walking capacity and quality of life | 6, 12, 24 and 36 months post-procedure | walking capacity as assessed by walking impairment questionnaire (WIQ), and 6 minutes' walk test |
| Quality of Life | 6, 12, 24 and 36 months post-procedure | quality of life assessed by EQ5D questionnaire |
Countries
Italy
Contacts
Primary ContactMaria Salomone, MD
Backup ContactMaria Letizia Lunetto, D.Sc.PT
Outcome results
None listed