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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04649190
Other study ID # SHEBA-13-0685-IB-CTIL-B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Transcatheter Aortic Valve Replacement

Intervention

Device:
TAVI
Coronary access for PCI after TAVI

Locations

Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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