Post-TAVI Coronary Access Study

Study Overview
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Brief Summary
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Coronary access after trans-catheter aortic valve implantation (TAVI) remains a major challenge. With the evolution of TAVI procedure and the inclusion of lower-risk patients with aortic stenosis, future coronary access is an even greater concern, because this lower-risk patient group has a greater cumulative risk of requiring coronary angiography for acute coronary events compared to their octogenarian counterparts. It is only speculated that the intra-annular position of the self-expandable valves together with the frame covering coronary ostia would impose a significant technical challenge as compared to the balloon-expandable valve (1). However, this remains to be proven. With any valve used, increased catheter manipulations may result in longer fluoroscopy times, larger volumes of contrast, and reduced imaging quality due to non-selective injections (2). Although complex, coronary procedures after TAVR are considered relatively safe and feasible on experience hands (3-6). A number of techniques to increase the likelihood of successful coronary intubation after TAVR have been described in the published reports and include the use of intracoronary guidewires (1), as well as balloon-assisted tracking with guideliner extension (7). It is therefore essential to fully understand the potential challenges of coronary angiography and PCI in this specific patient population. Guidance by a specific algorithm may help to overcome difficulties in coronary angiography and facilitate selective coronary intubation particularly during primary PCI (8).

Official Title
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Post-TAVI Coronary Access Study

Conditions
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Transcatheter Aortic Valve Replacement

Intervention / Treatment
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* Device: TAVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve Clinical indication for PCI Exclusion Criteria: Prior TAVI valve-in-valve procedures Prior TAVI-in-TAVI procedures

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI<br> | Device: TAVI<br>* Coronary access for PCI after TAVI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCI device success |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion |  | 5 year | 
| Successful withdrawal of the device delivery system |  | 5 year | 
| Attainment of a final in-stent or in-scaffold residual stenosis of <20% |  | 5 year | 
| Final TIMI flow |  | 5 year | 
| Successful selective engagement of guiding catheter |  | 5 year | 
| Incidence of procedural complications |  | 5 year | 
| Procedural mortality |  | 5 year |