GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device
研究概览
简要总结
Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
详细描述
This is a prospective, multicenter, observational registry to collect real world data of the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) device.
The registry population will include subjects presenting with clinical conditions consistent with the BXB device indications for use and in accordance with standard of care. The following subject cohorts will be included in the registry:
- De novo or restenotic lesions in the iliac arteries including lesions at the aortic bifurcation [Aortoiliac occlusive disease (AIOD)],
- De novo or restenotic lesions in the visceral arteries [Visceral artery occlusive disease (VAOD)],
- Isolated visceral, iliac, and subclavian artery aneurysms [IAA], or
- Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) [Arterial Injury (AI)].
To satisfy a key objective of the PMCF plan, clinical data will be collected in other indications outside of those listed above (Other cohort).
Approximately 24 clinical investigative sites in Europe, will participate in this registry. 240 subjects will be implanted in this study with a limit of 48 subjects treated / implanted per site. If a site reaches 48 subjects, enrolment will be closed for that site. All subjects will be followed through 12 months (1 year) post-procedure per standard of care. Quality of Life questionnaires will also be collected for all follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Informed Consent Form (ICF) is signed by subject
- •Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device
- •Willingness of the subject to adhere to institutional standard of care follow-up requirements
排除标准
- •Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).
- •Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
- •Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- •Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
- •Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
- •Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.
- •Pregnant or breast-feeding subject at time of informed consent signature.
- •Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
研究组 & 干预措施
Aortoiliac Occlusive Disease: De novo or rest. lesions in the iliac arteries include aortic bifurcat
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
干预措施: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) (Device)
Visceral Artery Occlusive Disease (VAOD): De novo or restenotic lesions in the visceral arteries
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
干预措施: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) (Device)
Isolated Artery Aneurysmal Disease (IAA): Isolated visceral, iliac, and subclavian artery aneurysms
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
干预措施: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) (Device)
Trauma or Iatrogenic Vessel Injury: are located in the chest cavity, abdominal cavity, or pelvis
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
干预措施: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) (Device)
Other (subjects not fitting into the categories above)
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
干预措施: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) (Device)
结局指标
主要结局
Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device
时间窗: within 30 days after the treatment
No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
Procedural Success for patients treated with BXB device
时间窗: at the time of implant
Successful access, delivery and deployment of BXB device, and withdrawal of catheters with patent BXB device at end of procedure
次要结局
- Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up(from the time of the index procedure up to 365 days (±window, between days 335 and 455))
- Freedom from major amputation of the BXB device treated limb for patients treated in AIOD(from the time of the index procedure up to 365 days (±window, between days 335 and 455))
- Primary patency for patients treated in Visceral Occlusive Disease (VAOD)(from the time of the index procedure up to 365 days (±window, between days 335 and 455))
- Survival for patients treated in VAOD(from the time of the index procedure up to 365 days (±window, between days 335 and 455))
- Freedom from reintervention through 1 year follow-up for patients treated in Isolated Artery Aneurysm (Subclavian, Visceral, Iliac)(from the time of the index procedure up to 365 days (±window, between days 335 and 455))
- 30 Day Mortality for patients treated in IAA(from the time of the index procedure through 30 days)
- Treated vessel primary patency through 1 year follow-up for patients treated Trauma or Iatrogenic Vessel Injury(from the time of the index procedure up to 365 days (±window, between days 335 and 455))
- Device-related adverse events (i.e. thrombosis) for patients treated in Trauma or or Iatrogenic Vessel Injury(from the time of the index procedure up to 365 days (±window, between days 335 and 455))