Transcatheter Aortic Valve ReplacementPTCANCT04649190
Post-TAVI Coronary Access Study
An observational study of Transcatheter Aortic Valve Replacement, run by Sheba Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- TAVI
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2010to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
- Clinical indication for PCI
Who cannot join
- Prior TAVI valve-in-valve procedures
- Prior TAVI-in-TAVI procedures
Trial locations and contacts
1 site in 1 country.
About this 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).
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- TAVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVIDevice
Coronary access for PCI after TAVI
| Study group | Role | What they receive |
|---|---|---|
| TAVI | Not described Receives: Device: TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCI device success
Measured: 5 year
Secondary outcomes (7)
Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion
Measured: 5 year
Successful withdrawal of the device delivery system
Measured: 5 year
Attainment of a final in-stent or in-scaffold residual stenosis of <20%
Measured: 5 year
Final TIMI flow
Measured: 5 year
Successful selective engagement of guiding catheter
Measured: 5 year
Incidence of procedural complications
Measured: 5 year
Procedural mortality
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jan 2010
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Issi Barbash, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649190
- Sponsor's protocol ID
- SHEBA-13-0685-IB-CTIL-B
- Acronym
- PTCA
- Status last verified
- Jun 2023
- First submitted
- 24 Nov 2020
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-TAVI Coronary Access Study
- ClinicalTrials.gov ID
- NCT04649190
- Acronym / sponsor ID
- PTCA / SHEBA-13-0685-IB-CTIL-B
- Conditions
- Transcatheter Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI | – | Device: TAVI |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
- Clinical indication for PCI
Key exclusion criteria (2 listed)
- Prior TAVI valve-in-valve procedures
- Prior TAVI-in-TAVI procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVICoronary access for PCI after TAVI | Device | TAVI |
Primary outcome
PCI device success
Time frame: 5 year
7 secondary outcomes
Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion
Time frame: 5 year
Successful withdrawal of the device delivery system
Time frame: 5 year
Attainment of a final in-stent or in-scaffold residual stenosis of <20%
Time frame: 5 year
Final TIMI flow
Time frame: 5 year
Successful selective engagement of guiding catheter
Time frame: 5 year
Incidence of procedural complications
Time frame: 5 year
Procedural mortality
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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The JenaValve ALIGN-AR LVAD Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCI device success (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.