Surgical and the Percutaneous Approach to the Upper Extremity Access Clinical Trial
Official title:
SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry
| Verified date | November 2022 |
| Source | IRCCS San Raffaele |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.
| Status | Completed |
| Enrollment | 700 |
| Est. completion date | February 28, 2022 |
| Est. primary completion date | February 28, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients who received a surgical or percutaneous access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting, between January 2010 and May 2020 - Adult patients =18 years Exclusion Criteria: - Introducer sheath internal diameter (ID) used < 5F or > 22F - Patient with previous surgical axillary access on the puncture side (Pacemaker excluded) - Patient with subclavian / axillary / brachial occlusive disease with stenosis greater than 50% - Patient with previous bypass surgery or stent placement in the vicinity of access site (ie. Axillary extracorporeal cannulation with, axillo-femoral bypass, patch (venous or synthetic repair of previous axillary access, etc) - Bleeding diathesis or coagulopathy - Patients with active systemic or cutaneous infection or inflammation - Patients who are pregnant or lactating - Patient younger than 18 years of age - Patients who are morbidity obese (BMI > 40 Kg/m2) |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna | |
| Belgium | Imelda Hospital | Bonheiden | |
| France | Service de Chirurgie Thoracique et Cardiovasculaire | Rennes | |
| Germany | University Hospital of Cologne | Cologne | |
| Germany | Asklepios Klinik St. Georg | Hamburg | |
| Germany | University Heart and Vascular Center Hamburg | Hamburg | |
| Germany | University Hospital Hamburg-Eppendorf | Hamburg | |
| Germany | University hospital Leipzig | Leipzig | |
| Italy | IRCCS San Raffaele | Milan | |
| Italy | IRCCS San Raffaele Hospital | Milan | |
| Italy | S. Maria della Misericordia Hospital | Perugia | |
| Italy | San Filippo Neri Hospital | Roma | |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| Spain | Hospital Álvaro Cunqueiro | Vigo | |
| Sweden | Skåne University Hospital | Malmö | |
| Switzerland | UniversitätsSpital Zürich | Zürich | |
| United Kingdom | Nuffield Dept. of Clinical Neurosciences, University of Oxford | Oxford | |
| United States | Ascension St John Hospital and Medical Center | Detroit | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele |
United States, Austria, Belgium, France, Germany, Italy, Spain, Sweden, Switzerland, United Kingdom,
Arnett DM, Lee JC, Harms MA, Kearney KE, Ramos M, Smith BM, Anderson EC, Tayal R, McCabe JM. Caliber and fitness of the axillary artery as a conduit for large-bore cardiovascular procedures. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):150-156. doi: 10.1002/ccd.27416. Epub 2017 Nov 11. — View Citation
Bertoglio L, Grandi A, Melloni A, Kahlberg A, Melissano G, Chiesa R. Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):929-938. doi: 10.1016/j.ejvs.2020.01.027. Epub 2020 Feb 20. — View Citation
Branzan D, Steiner S, Haensig M, Scheinert D, Schmidt A. Percutaneous Axillary Artery Access for Endovascular Treatment of Complex Thoraco-abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2019 Sep;58(3):344-349. doi: 10.1016/j.ejvs.2019.01.011. Epub 2019 Jul 30. — View Citation
De Palma R, Rück A, Settergren M, Saleh N. Percutaneous axillary arteriotomy closure during transcatheter aortic valve replacement using the MANTA device. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):998-1001. doi: 10.1002/ccd.27383. Epub 2017 Oct 25. — View Citation
Deuschl F, Schofer N, Seiffert M, Hakmi S, Mizote I, Schaefer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schäfer U. Direct percutaneous transaxillary implantation of a novel self-expandable transcatheter heart valve for aortic stenosis. Catheter Cardiovasc Interv. 2017 Dec 1;90(7):1167-1174. doi: 10.1002/ccd.26986. Epub 2017 Mar 15. — View Citation
Fröhlich GM, Baxter PD, Malkin CJ, Scott DJ, Moat NE, Hildick-Smith D, Cunningham D, MacCarthy PA, Trivedi U, de Belder MA, Ludman PF, Blackman DJ; National Institute for Cardiovascular Outcomes Research. Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry). Am J Cardiol. 2015 Nov 15;116(10):1555-9. doi: 10.1016/j.amjcard.2015.08.035. Epub 2015 Sep 3. — View Citation
Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1. — View Citation
Malgor RD, Marques de Marino P, Verhoeven E, Katsargyris A. A systematic review of outcomes of upper extremity access for fenestrated and branched endovascular aortic repair. J Vasc Surg. 2020 May;71(5):1763-1770.e2. doi: 10.1016/j.jvs.2019.09.028. Epub 2019 Nov 15. — View Citation
Mirza AK, Oderich GS, Sandri GA, Tenorio ER, Davila VJ, Kärkkäinen JM, Hofer J, Cha S. Outcomes of upper extremity access during fenestrated-branched endovascular aortic repair. J Vasc Surg. 2019 Mar;69(3):635-643. doi: 10.1016/j.jvs.2018.05.214. Epub 2018 Oct 24. — View Citation
Puippe GD, Kobe A, Rancic Z, Pfiffner R, Lachat M, Pfammatter T. Safety of percutaneous axillary artery access with a suture-mediated closing device for parallel endograft aortic procedures - a retrospective pilot study. Vasa. 2018 Jun;47(4):311-317. doi: — View Citation
Schaefer A, Schirmer J, Schofer N, Schneeberger Y, Deuschl F, Blankenberg S, Reichenspurner H, Conradi L, Schäfer U. Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study. Clin Res Cardiol. 2019 Jul;108(7):779-786. doi: 10.1007/s00392-018-1407-z. Epub 2018 Dec 17. — View Citation
Schäfer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck KH, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol. 2017 Apr 1;232:247-254. doi: 10.1016/j.ijcard.2017.01.010. Epub 2017 Jan 7. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | optimal hemostasis | Closure success rate of the procedure without any adjunctive procedures | 30 days | |
| Primary | vascular complications | freedom from major access vascular complications requiring adjunctive endovascular or open procedures | 30 days | |
| Primary | Incidence of permanent peripheral nerve injury | freedom from permanent peripheral nerve injury with functional compromise | 30 days | |
| Primary | stroke Incidence | freedom from periprocedural stroke | periprocedural | |
| Primary | Durability of vessel closure | freedom from secondary intervention at access site | 30 days |