Clinical trial NCT04649190: Post-TAVI Coronary Access Study
Official title: Post-TAVI Coronary Access Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-12-02
Enrollment: 200
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent TAVI at any time point prior to index PCI procedure, and who have clinical indication for PCI will be included in the present study. Consecutive subjects of both genders will be enrolled at various sites in Europe, United States and Asia (See Appendix 1). The study procedures, clinical management and follow up will be done at each participating center.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
2. Clinical indication for PCI

Exclusion Criteria:

1. Prior TAVI valve-in-valve procedures
2. Prior TAVI-in-TAVI procedures

Primary outcomes:
measure: PCI device success
timeFrame: 5 year
Secondary outcomes:
measure: Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion
timeFrame: 5 year
measure: Successful withdrawal of the device delivery system
timeFrame: 5 year
measure: Attainment of a final in-stent or in-scaffold residual stenosis of <20%
timeFrame: 5 year
measure: Final TIMI flow
timeFrame: 5 year
measure: Successful selective engagement of guiding catheter
timeFrame: 5 year
measure: Incidence of procedural complications
timeFrame: 5 year
measure: Procedural mortality
timeFrame: 5 year
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: