|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
10 October 2016 |
|
Main ID: |
NCT01658540 |
|
Date of registration:
|
31/07/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Drug Eluting Balloon (DEB) and Long Lesions of Superficial Femoral Artery (SFA) Ischemic Vascular Disease
DEB-SFA-LONG |
|
Scientific title:
|
Safety and Efficacy of the Drug Eluting Balloon (DEB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With Long Lesions: a Pilot Study |
|
Date of first enrolment:
|
October 2012 |
|
Target sample size:
|
105 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01658540 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Antonio Micari, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Maria Eleonora Hospital, GVM Care & Research |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries
according to Rutherford Category 2, 3 or 4;
- Target lesion consists of a single solitary or multiple adjacent de novo or
restenotic lesions (non-in-stent) with diameter stenosis = 70% by visual estimate and
cumulative lesion length = 15 cm;
- Target vessel is the superficial femoral artery and/or proximal popliteal artery
(above the knee);
- Life expectancy >1 year in the Investigator's opinion;
- Written informed consent.
Exclusion criteria:
Given the observational nature of the study, no study-specific but only clinical exclusion
criteria will apply:
- Patient unwilling or unlikely to comply with FU schedule;
- Administration of local or systemic thrombolytic therapy within 48 hours prior to the
index procedure;
- Known allergies or sensitivities to heparin, aspirin, other
anticoagulant/antiplatelet therapies, and/or paclitaxel;
- Additional planned cardiac or peripheral percutaneous or surgical intervention
including CABG within 30 days following the study procedure;
- 15 cm long inflow lesion (=50% DS) or occlusion (any length) in the ipsilateral
Iliac artery;
- Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac
artery
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Peripheral Artery Disease
|
|
Primary Outcome(s)
|
|
rate of primary patency
[Time Frame: within the first 12 months after percutaneous treatment]
|
|
Secondary Outcome(s)
|
|
incidence of Major Adverse Cardiac and Cerebrovascular event (MACCE)
[Time Frame: within the first 24 months after percutaneous treatment]
|
|
clinical improvement as assessed by Rutherford Class changes
[Time Frame: within 6, 12 and 24 months vs baseline]
|
|
composite of all Major Adverse Events (MAE)
[Time Frame: within the first 24 months after percutaneous treatment]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|