Post-TAVI Coronary Access Study (PTCA)

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).

Study Overview

• Status: Completed
• Conditions: Transcatheter Aortic Valve Replacement
• Intervention / Treatment: Device: TAVI

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAVI	Device: TAVI; Coronary access for PCI after TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PCI device success	5 year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHEBA-13-0685-IB-CTIL-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No