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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05153083
Other study ID # Cryo Registry
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date December 31, 2024
Est. completion date December 30, 2026

Study information

Verified date January 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the registry is to evaluate the peri-operative and short- term outcomes of intercostal nerves cryoablation for post-operative pain control after open thoracic and thoracoabdominal aortic aneurysms repair. The cryoablation procedure is one of the opportunities for pain control after thoracotomy. So, it is routinely performed in major several centers in aortic surgery around the world as a part of the TAA and TAAA procedure. The Registry will include approximately 200 patients treated from January 2022 to January 2024 for thoracic or thoracoabdominal aortic aneurysm by means of open surgery and in whom intraoperative intercostal nerves cryoablation will be performed; to reach 200 patients, the enrolments can be extended until January 2027.


Recruitment information / eligibility

Status Suspended
Enrollment 200
Est. completion date December 30, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients =18 years - Patients who will undergo TAA and TAAA open repair with intraoperative intercostal nerves cryoablation - Subject has consented for study participation and signed the approved Informed Consent Exclusion Criteria: - Patients with active systemic or cutaneous infection or inflammation - Patients who are pregnant or breastfeeding - Patients younger than 18 years of age - Unwilling or unable to comply with the follow-up schedule - Inability or refusal to give informed consent - Frank rupture - Previous stroke with neurological sequelae

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Open thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)
Each participating center will be able to use its preferred European Conformity marked device, for cryoablation according to their normal clinical practice and according to the instructions for use.

Locations

Country Name City State
Austria Hospital Hietzing,Vienna Vienna
France Salpetriere University Hospital Paris
Germany University Hospital Freiburg Freiburg
Germany University Medical Center Hamburg Hamburg
Germany University Medical Center Hamburg-Eppendorf Hamburg
Germany Hannover Medical School Hannover
Germany Saarland University Hospital Homburg
Italy Policlinico S. Orsola - Malpighi Bologna
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma
Netherlands Maastricht University Medical Center Maastricht
Portugal Centro Hospitalar de Entre o Douro e Vouga Santa Maria Da Feira
Switzerland University Hospital of Bern Bern
United Kingdom St Bartholomew's Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Germano Melissano

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

References & Publications (10)

Achouh PE, Madsen K, Miller CC 3rd, Estrera AL, Azizzadeh A, Dhareshwar J, Porat E, Safi HJ. Gastrointestinal complications after descending thoracic and thoracoabdominal aortic repairs: a 14-year experience. J Vasc Surg. 2006 Sep;44(3):442-6. doi: 10.1016/j.jvs.2006.05.018. — View Citation

Carlsson CA, Persson K, Pelletieri L. Painful scars after thoracic and abdominal surgery. Acta Chir Scand. 1985;151(4):309-11. — View Citation

Chaikof EL, Fillinger MF, Matsumura JS, Rutherford RB, White GH, Blankensteijn JD, Bernhard VM, Harris PL, Kent KC, May J, Veith FJ, Zarins CK. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1061-6. doi: 10.1067/mva.2002.123991. No abstract available. — View Citation

Clemence J Jr, Malik A, Farhat L, Wu X, Kim KM, Patel H, Yang B. Cryoablation of Intercostal Nerves Decreased Narcotic Usage After Thoracic or Thoracoabdominal Aortic Aneurysm Repair. Semin Thorac Cardiovasc Surg. 2020 Autumn;32(3):404-412. doi: 10.1053/j.semtcvs.2020.01.008. Epub 2020 Jan 20. — View Citation

Gottschalk A, Cohen SP, Yang S, Ochroch EA. Preventing and treating pain after thoracic surgery. Anesthesiology. 2006 Mar;104(3):594-600. doi: 10.1097/00000542-200603000-00027. No abstract available. — View Citation

Johnston KW, Rutherford RB, Tilson MD, Shah DM, Hollier L, Stanley JC. Suggested standards for reporting on arterial aneurysms. Subcommittee on Reporting Standards for Arterial Aneurysms, Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg. 1991 Mar;13(3):452-8. doi: 10.1067/mva.1991.26737. — View Citation

Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009. — View Citation

Riambau V, Bockler D, Brunkwall J, Cao P, Chiesa R, Coppi G, Czerny M, Fraedrich G, Haulon S, Jacobs MJ, Lachat ML, Moll FL, Setacci C, Taylor PR, Thompson M, Trimarchi S, Verhagen HJ, Verhoeven EL, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus ES, Hinchliffe RJ, Kakkos S, Koncar I, Lindholt JS, Vega de Ceniga M, Vermassen F, Verzini F, Document Reviewers, Kolh P, Black JH 3rd, Busund R, Bjorck M, Dake M, Dick F, Eggebrecht H, Evangelista A, Grabenwoger M, Milner R, Naylor AR, Ricco JB, Rousseau H, Schmidli J. Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):4-52. doi: 10.1016/j.ejvs.2016.06.005. No abstract available. — View Citation

Richardson J, Sabanathan S, Shah R. Post-thoracotomy spirometric lung function: the effect of analgesia. A review. J Cardiovasc Surg (Torino). 1999 Jun;40(3):445-56. — View Citation

Soto RG, Fu ES. Acute pain management for patients undergoing thoracotomy. Ann Thorac Surg. 2003 Apr;75(4):1349-57. doi: 10.1016/s0003-4975(02)04647-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary technical success Freedom from Death From Admission to 1 years
Primary change in dose of narcotic administration reduction opioids usage for thoracic incision pain From Admission to 1 years
Primary Primary clinical success pain control defined as a visual analogic scale < 5 in the perioperative period up to the discharge up to 3 weeks
Primary secondary clinical success pain control in in the perioperative period up to the discharge, using analgesic non opioids drugs up to 3 weeks
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