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Completed

NCT Number: NCT04649190

Post-TAVI Coronary Access Study

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).

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Key information

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba Medical Center

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVI

Device

Coronary access for PCI after TAVI

Primary outcomes

  1. PCI device success

    Time frame: 5 year

Secondary outcomes

  1. Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion

    Time frame: 5 year

  2. Successful withdrawal of the device delivery system

    Time frame: 5 year

  3. Attainment of a final in-stent or in-scaffold residual stenosis of <20%

    Time frame: 5 year

  4. Final TIMI flow

    Time frame: 5 year

  5. Successful selective engagement of guiding catheter

    Time frame: 5 year

  6. Incidence of procedural complications

    Time frame: 5 year

  7. Procedural mortality

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Acronym: PTCA

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2020
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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