PTCA: Post-TAVI Coronary Access Study

Sponsor

Sheba Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04649190

Collaborator

(none)

500

Enrollment

Location

156

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Transcatheter Aortic Valve Replacement	Device: TAVI

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Post-TAVI Coronary Access Study

Actual Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
TAVI	Device: TAVI Coronary access for PCI after TAVI

Outcome Measures

Primary Outcome Measures

PCI device success [5 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat Gan		Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Issi Barbash, Prof, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT04649190

Other Study ID Numbers:

SHEBA-13-0685-IB-CTIL-B

First Posted:

Dec 2, 2020

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 5, 2022