Call for Independent Research: Physician-Modified Endografts (PMEGs) and/or In-Situ Fenestration for Complex Aortic Disease

Purpose

Gore is interested in supporting independent, investigator-initiated research conducted by qualified healthcare professionals involved in the diagnosis and treatment of patients with complex aortic disease for whom physician-modified endografts (PMEGs) or in-situ fenestrations are used or considered in contemporary clinical practice.

Research grant funding may be provided for proposals that advance scientific and clinical understanding of PMEG and/or in-situ fenestration use in visceral and aortic arch applications, including patient selection, procedural planning, modification techniques, technical success, and short- and long-term clinical and imaging outcomes.  The intent of this request is to support objective evidence generation that can inform clinical decision-making, procedural best practices, and future research in complex endovascular aortic repair.

Successful proposals are expected to have a clear research question, appropriate study design, qualified investigators, and the ability to collect reliable clinical and imaging data.  Multicenter collaboration is encouraged when it improves generalizability, patient diversity, and statistical power.  Meaningful follow-up through at least 1 year, and preferably up to 5 years when feasible, is encouraged.

Gore support for independent research is intended to foster objective scientific inquiry.  All funded research must be independently designed, conducted, analyzed, and reported by the investigator.  Funding decisions are not related to, and are not conditioned upon, the use, purchase, or recommendation of any Gore product.

Research Needs

PMEGs and in-situ fenestrations are used by physicians to treat selected patients with complex abdominal, thoracoabdominal, or thoracic aortic disease, particularly when anatomy, urgency, comorbidity, or access to custom-manufactured devices limits standard treatment options.  Published evidence suggests PMEGs can achieve high technical success in experienced centers, but outcomes vary by patient risk, anatomy, aortic segment, urgency of presentation, device platform, modification method, and follow-up practices [1-4].

Important evidence gaps remain.  Additional research is needed to better understand which patients are most appropriate for PMEG and in-situ fenestration repair, which procedural approaches are associated with durable outcomes, and how modification techniques influence technical success, complications, reintervention, and long-term aortic remodeling.  Research that includes thoracic and visceral PMEG/in-situ fenestration applications may help clarify how outcomes and best practices differ by anatomy and treatment objective.

Areas of interest include:

• Technical and procedural success, including device preparation, delivery, deployment, target-vessel incorporation, and completion imaging findings.
• Short- and long-term outcomes, including 30-day events, major adverse events, and follow-up through 1 to 5 years where feasible.
• Clinical outcomes such as mortality, stroke, target vessel patency, spinal cord ischemia, paraplegia or paraparesis, renal complications, endoleaks, rupture, open conversion, and secondary intervention.
• Thoracic, thoracoabdominal, and visceral PMEG or in-situ fenestration applications, including the number and configuration of branches and/or fenestrations needed to optimize outcomes.
• Physician-driven procedural techniques, including planning, branch/fenestration creation technique, diameter reduction and re-constraining techniques, target-vessel cannulation, and adjunctive component selection.
• Patient selection factors, including anatomic, clinical, urgency, frailty, comorbidity, and vascular access.
• Device compatibility and interaction among endograft platforms, bridging stents, stent grafts, and other adjunctive components used to complete complex aortic repair.
• Real-world outcomes of visceral and aortic arch endovascular repair in diverse patient populations and practice settings.

Investigators retain full control over study design, data collection, analysis, interpretation, and publication.  Studies should be conducted in accordance with applicable laws, regulations, institutional policies, and ethical standards.  Proposal budgets should include open access publication costs where possible.

Activity Design

Please submit your concept proposal via our Portal or to the Grants Program Coordinator (Grants_Program@wlgore.com, +1 623-234-5521).

Concept proposals should include the research question, study design, target population, data source, anticipated sample size, key endpoints, follow-up schedule, statistical approach, data dissemination plan, requested support, and investigator or site research capabilities.  For multicenter studies, proposals should describe how data collection, imaging review, endpoint definitions, and study coordination will be standardized.

Appropriate study designs may include prospective single-center or multicenter studies, registries, observational cohort studies, retrospective analyses with robust source data and imaging follow-up, or analyses of institutional, society, or national databases when the data source is sufficient to answer the proposed question.

Outcomes Measurement

The objective of this request is to support independent research that improves understanding of the safety, effectiveness, durability, and clinical decision-making in complex aortic disease using PMEG or in-situ fenestration techniques.

Proposed research should capture relevant patient factors, anatomy and pathology, urgency of presentation, device platform(s) used, modification method, procedural details, number and type of branches and/or fenestrations, adjunctive component use, and follow-up findings.  Endpoints may include technical success, target-vessel patency, endoleaks, aortic remodeling or sac behavior, rupture, conversion to open repair, planned and unplanned reintervention, stroke, spinal cord ischemia, renal outcomes, mortality, and patient-reported outcomes where feasible.

Studies should use standardized endpoint definitions and prespecified follow-up intervals whenever possible [5].  Proposals with independent imaging review, clinical event adjudication, and a clear plan for missing-data management will be viewed favorably.

Terms and Conditions

We reserve the right to approve or deny any or all applications received as a result of this request or to cancel, in part or in its entirety, this request for grants.  Gore is not responsible for any costs associated with a grant application.  Investigators will be responsible for obtaining all required regulatory approval for study conduct, as applicable.