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Coronary AngiographyCAN-ACCESSNCT05075590

Coronary Access After Supra-Annular THV Implantation

A study testing Coronary Angiography in people with Coronary Angiography and Transcatheter Aortic Valve Replacement, run by University of British Columbia at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary Angiography
How many people
50 participants
Where
4 sitesin 2 countries
Study dates
27 Oct 2021to 31 Jul 2024
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).
  • Written informed consent to participate in the study.

Who cannot join

  • Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR.
  • Advanced chronic kidney disease, defined as a GFR <30 ml/min.
  • Valve-in-valve TAVR
  • Prior CABG
  • Aorto-ostial coronary artery disease.
  • Prior PCI of the left main or right coronary ostium

Trial locations and contacts

4 sites in 2 countries.

Pavneet Grewal contact

604-875-4111 ext. 22959

pgrewal@cci-cic.org

4 sites in 2 countries

Canada3 sites, 3 recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Sulagna Sarker, MBBS, MPH, 416.480.6100 ext. 89723, sulagna.sarker@sunnybrook.ca

    Sam Radhakrishnan, MD

    Not yet recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

    Jackie Chow, 604.875.5324, jackie.chow@vch.ca

    Janarthanan Sathananthan, MBChB, MPH

    Recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Elizabeth Grieve, 604.682.2344 ext. 64980, egrieve@providencehealth.bc.ca

    Janarthanan Sathananthan, MBChB, MPH

    Recruiting

Other trials in Canada

United States1 site, 1 recruiting

  • UPMC Harrisburg

    Harrisburg, Pennsylvania, 17101

    Anita Todd, RN, CCRC, ACRP-MDP, 717.731.0101 ext. 3002, toddag@upmc.edu

    Hemal Gada, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: Coronary ANgiography and ACCESS Following Implantation of a Supra-Annular Transcatheter Heart Valve With Commissural Alignment: The CAN-ACCESS Pilot Study

To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.

Read the detailed description

Patients will undergo elective transfemoral TAVR with the Evolut THV. The operators will attempt to selectively engage both the right and left coronary arteries through standardized angiographic views. The CCI-CIC CoreLabs will adjudicate angiographic views, post-TAVR CT scan, and determine if the coronaries were selectively engaged. Catheter choice, adjunctive tools if needed (e.g guide extension, wires etc) and engagement technique will be at the discretion of the operator. All images and fluoroscopic views will be anonymized, saved and imported to the CCI-CIC Angiographic and CT CoreLabs.

Statistical analysis:

Patient baseline and outcome data will be presented as mean and standard deviation (SD) for normally distributed variables, median and interquartile range (IQR) for non-normally distributed variables, and frequency and proportion for categorical variables.

Being tested
Coronary Angiography
Keywords
elective transfemoral TAVR, Evolut valve, Supra-Annular Transcatheter Heart Valve, Commissural Alignment, Coronary Angiography, Transcatheter Aortic Valve Replacement, Coronary Access

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary AngiographyDiagnostic test

    Following TAVR, the operators will attempt to selectively engage both the right and left coronary arteries. Catheter choice and engagement technique will be at the discretion of the operator.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia

    Coronary engagement will be classified as:

    1. Partially successful if non-selective engagement is achieved (catheter is unable to be placed in the coronary ostia) and there is adequate opacification of the coronary vessels.
    2. Successful if selective engagement is achieved with placement of the coronary catheter in the coronary ostia and adequate opacification of the coronary vessels.
    3. Unsuccessful if engagement is not possible and there is insufficient opacification of the coronary vessels.

    Measured: Immediately post-TAVR

Secondary outcomes (5)

  1. Total fluoroscopic time (mins) from catheter insertion to selective coronary engagement.

    Measured: During TAVR procedure

  2. Total contrast use (ml) from catheter insertion to selective coronary engagement.

    Measured: During TAVR procedure

  3. Type of wire and catheter used for successful right and left coronary engagement

    Reporting of the wire and catheter type will be collected

    Measured: During TAVR procedure

  4. Total number and types of wires and catheters used.

    Measured: During TAVR procedure

  5. Description of type of technique utilized to achieve selective coronary engagement.

    Report of description will be collected

    Measured: During TAVR procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2021
  2. Study start27 Oct 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075590
Sponsor's protocol ID
H21-01704
Acronym
CAN-ACCESS
Status last verified
Dec 2023
First submitted
14 Sep 2021
Last updated
20 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Pilgrim T, Windecker S. Expansion of transcatheter aortic valve implantation: new indications and socio-economic considerations. Eur Heart J. 2018 Jul 21;39(28):2643-2645. doi: 10.1093/eurheartj/ehy228. No abstract available.

    PubMed 29701845

  • Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

    PubMed 30883058

  • Asgar AW, Ouzounian M, Adams C, Afilalo J, Fremes S, Lauck S, Leipsic J, Piazza N, Rodes-Cabau J, Welsh R, Wijeysundera HC, Webb JG. 2019 Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation. Can J Cardiol. 2019 Nov;35(11):1437-1448. doi: 10.1016/j.cjca.2019.08.011.

    PubMed 31679616

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.

    PubMed 28315732

  • Htun WW, Grines C, Schreiber T. Feasibility of coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement using a Medtronic self-expandable bioprosthetic valve. Catheter Cardiovasc Interv. 2018 Jun;91(7):1339-1344. doi: 10.1002/ccd.27346. Epub 2017 Oct 8.

    PubMed 28988450

  • Yudi MB, Sharma SK, Tang GHL, Kini A. Coronary Angiography and Percutaneous Coronary Intervention After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2018 Mar 27;71(12):1360-1378. doi: 10.1016/j.jacc.2018.01.057.

    PubMed 29566822

  • Boukantar M, Gallet R, Mouillet G, Belarbi A, Rubimbura V, Ternacle J, Dubois-Rande JL, Teiger E. Coronary Procedures After TAVI With the Self-Expanding Aortic Bioprosthesis Medtronic CoreValve, Not an Easy Matter. J Interv Cardiol. 2017 Feb;30(1):56-62. doi: 10.1111/joic.12363. Epub 2017 Jan 11.

    PubMed 28078734

  • Blumenstein J, Kim WK, Liebetrau C, Gaede L, Kempfert J, Walther T, Hamm C, Mollmann H. Challenges of coronary angiography and intervention in patients previously treated by TAVI. Clin Res Cardiol. 2015 Aug;104(8):632-9. doi: 10.1007/s00392-015-0824-5. Epub 2015 Feb 27.

    PubMed 25720330

  • Barbanti M, Costa G, Picci A, Criscione E, Reddavid C, Valvo R, Todaro D, Deste W, Condorelli A, Scalia M, Licciardello A, Politi G, De Luca G, Strazzieri O, Motta S, Garretto V, Veroux P, Giaquinta A, Giuffrida A, Sgroi C, Leon MB, Webb JG, Tamburino C. Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2542-2555. doi: 10.1016/j.jcin.2020.07.006. Epub 2020 Oct 14.

    PubMed 33069648

  • Abdelghani M, Landt M, Traboulsi H, Becker B, Richardt G. Coronary Access After TAVR With a Self-Expanding Bioprosthesis: Insights From Computed Tomography. JACC Cardiovasc Interv. 2020 Mar 23;13(6):709-722. doi: 10.1016/j.jcin.2020.01.229.

    PubMed 32192691

  • Tang GHL, Zaid S, Fuchs A, Yamabe T, Yazdchi F, Gupta E, Ahmad H, Kofoed KF, Goldberg JB, Undemir C, Kaple RK, Shah PB, Kaneko T, Lansman SL, Khera S, Kovacic JC, Dangas GD, Lerakis S, Sharma SK, Kini A, Adams DH, Khalique OK, Hahn RT, Sondergaard L, George I, Kodali SK, De Backer O, Leon MB, Bapat VN. Alignment of Transcatheter Aortic-Valve Neo-Commissures (ALIGN TAVR): Impact on Final Valve Orientation and Coronary Artery Overlap. JACC Cardiovasc Interv. 2020 May 11;13(9):1030-1042. doi: 10.1016/j.jcin.2020.02.005. Epub 2020 Mar 16.

    PubMed 32192985

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Angiography in people with Coronary Angiography and Transcatheter Aortic Valve Replacement, run by University of British Columbia at 4 sites in 2 countries.

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 6 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, United States. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pavneet Grewal (604-875-4111 ext. 22959, pgrewal@cci-cic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia (time frame: Immediately post-TAVR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05075590, which also lists 11 linked publications.

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 20 Dec 2023.

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