Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will validate the efficacy and safety of the VESTO® Vascular Stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial
Multicenter study aimed at collecting post-market clinical data on the VESTO® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. The objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the Vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Stent - Vesto Endoprosthesis | Device | Vascular Stent Implant - Vesto Endoprosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device-Related Serious Adverse Events (Device Safety) | Absence of major serious adverse events occurring within 30 days after the index procedure, defined as device- or procedure-related death, acute myocardial infarction (AMI), or above-the-metatarsal amputation in the treated leg due to a vascular event | 30 days post-index procedure |
| Number of Patients with Technical Success (Device Performance) | Technical success with the absence of serious adverse events related to the device | Intraoperative |
| Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome) | Absence of rupture or dissection of the treated vessel within 30 days after the procedure | 30 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Technical Success | Defined as the successful deployment of the endoprosthesis at the intended site with patency and absence of significant device deformities (e.g., kinks, stent eversion, twisting) | Intraoperative |
| Rate of Procedural Success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glaucia Basso | Contact | +55 (17) 2136-7005 | glaucia.basso@braile.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Fabio Cypreste Oliveira | Hospital Santa Helena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ana Nery | Recruiting | Salvador | Estado de Bahia | 40301-155 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Defined as the absence of serious adverse events related to the device within 30 days
| 30 days post index procedure |
| Incidence of Adverse Events | Defined as device- or procedure-related death, bleeding or hematoma, myocardial infarction (MI), thrombosis, arterial rupture or dissection, or amputation above the metatarsal in the treated leg due to a vascular event | 30 days, 3, 6, 9, and 12 months |
| Conversion Rate to Open Surgery | Rate of patients who required conversion to open surgery | Intraoperative |
| Primary Patency Rate | Defined as the absence of restenosis > 50% within 30 days | 30 days post index procedure |
| Number of Patients with Clinical Success | Defined by symptom improvement | 30 days, 3, 6, 9, and 12 months |
| Rate of Target Vessel Patency | Absence of restenosis > 50% | 3, 6, 9, and 12 months |
| Limb Salvage Rate | When patients with rest pain experienced pain relief and those with foot ulcers showed improved perfusion, avoiding the need for amputation | 30 days, 6, 9, and 12 months |
| Need for Endovascular Reintervention at the Target Lesion | Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention | 30 days, 3, 6, 9, and 12 months |
| Hospital Santa Helena | Recruiting | Goiânia | Goiás | 74083-100 | Brazil |
|
| Hospital Universitário Pedro Ernesto (HUPE-UERJ) | Recruiting | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
|
| HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista | Recruiting | Botucatu | São Paulo | 18618-970 | Brazil |
|
| Hospital de Clínicas da Universidade Estadual de Campinas | Not yet recruiting | Campinas | São Paulo | 13083-888 | Brazil |
|
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Recruiting | Ribeirão Preto | São Paulo | 14015-010 | Brazil |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided