Peripheral Artery Disease
Conditions
Keywords
Peripheral Artery Disease, Revascularization, Graft, Vein, Artery, Limb, Amputation
Brief summary
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.
Detailed description
The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.
Interventions
PROCEDURERevascularization using a BIOPROTEC Graft
It is about a routine care study not changing the usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular Doctor in 1 month, 6 months, 12 months, 18 months and 2 years.
Sponsors
Hôpital NOVO
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ Eighteen years old. * Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.
Exclusion criteria
* Pregnant woman. * Patient with an acute ischemia. * Patient with an exceeded ischemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Limb rescue rate one year after a BIOPROTEC graft | Two years | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The revascularization permeability rate | Two years | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years |
| The amputation rate | Two years | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years |
| Infection resistance rate | Two years | Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years |
Countries
France
Outcome results
None listed