Peripheral Vascular Diseases
Conditions
Keywords
Lesion-exclusion, Visceral Perfusion, Luminal Reconstruction, Occlusive Disease
Brief summary
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment
Interventions
DEVICEGORE VIABAHN VBX Balloon Expandable Endoprosthesis
GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Signed informed consent form * Endovascular indication for treatment based on treating physician's best medical judgment. * Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement. * Willingness of the patient to adhere to standard of care follow-up requirements.
Exclusion criteria
* Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. * Participation in concurrent research study or registry which may confound registry results, unless approved by Gore. * Pregnant or breast-feeding female at time of informed consent signature. * Life expectancy \< 12 months due to comorbidities. * Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease. * Use of the VBX Stent Graft is for the treatment of aortic coarctations. * Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events | 30 days post treatment | Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure. |
Countries
France, Germany, Italy, Netherlands, Spain
Contacts
PRINCIPAL_INVESTIGATORMauro Gargiulo, MD
Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment. | 280 |
| Total | 280 |
Baseline characteristics
| Characteristic | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 212 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Age, Continuous | 70.7 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment France | 8 Participants |
| Region of Enrollment Germany | 92 Participants |
| Region of Enrollment Italy | 77 Participants |
| Region of Enrollment Netherlands | 60 Participants |
| Region of Enrollment Spain | 43 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 49 / 280 |
| other Total, other adverse events | 15 / 280 |
| serious Total, serious adverse events | 153 / 280 |
Outcome results
Primary
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.
Time frame: 30 days post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events | 274 Participants |