Results of Coronary Angiography Rafter CABG: Comparison Between No-touch and Conventional Vein Graft

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ClinicalTrials.gov Identifier: NCT04656366

Recruitment Status : Recruiting

First Posted : December 7, 2020

Last Update Posted : December 8, 2020

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Sponsor:

Information provided by (Responsible Party):

Gabriele Ferrari, Region Örebro County

Study Description

Brief Summary:

Coronary artery disease is one of the biggest health issue worldwide: It is estimated that cardiovascular diseases cause around 45% of all death in Sweden and in the West World. The treatment, in a large part of the patients, implicates a so called bypass-operation, that consists in to connect new vascular conduits (grafts) beyond the narrowed coronary vessels to improve the blood supply to the heart. One of the graft that is commonly used is the saphenous vein from the leg. The disadvantage of the saphenous vein graft is the predisposition to early obstruction. The international literature shows the following grades of occlusion: 15% in the first year and 40% after 10 years.

At the Cardio-Thoracic Clinic of the University hospital of Örebro has been developed a new method to harvest the saphenous vein together with the surrounding fat-tissue. This technique, called no-touch technique, has the advantage to reduce the damages to the vein during the harvesting, showing a substantially reduced risk for future occlusion (5% after 18 months and 10% after 8,5 years).

2020-05-20 2020-11-16 Project created in: FoU Region Örebro län Resultat av Koronarangiografi hos patienter som tidigare CABG opererats Project number : 274418 Created by: Gabriele Ferrari, 2020-05-20 Last revised by: Gabriele Ferrari, 2020-11-16 Ongoing The aim of the PhD project is to evaluate the results of the no-touch technique in compare to the conventional technique for the venous graft harvesting. The focus of the study is to analyze all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). One will compare the patency rate, the rate of MACE (major adverse cardiac events) and the quality of life in the two groups (no-touch vs. conventional). This study is the first and the only one in the world that will examine the long-term angiographic results of the no-touch technique in patients that had angina pectoris after the operation.

Condition or disease	Intervention/treatment
Bypass Graft Stenosis	Diagnostic Test: Coronary Angiography

Study Design

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Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Coronary Angiographical Results in Patients With Angina After CABG: Comparison Between No-touch and Conventional Vein Graft
Actual Study Start Date :	November 1, 2020
Estimated Primary Completion Date :	December 1, 2021
Estimated Study Completion Date :	February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
No-touch Participants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft.	Diagnostic Test: Coronary Angiography Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention) Other Name: Previously: coronary artery bypass grafting (CABG)
Conventional Participants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft.	Diagnostic Test: Coronary Angiography Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention) Other Name: Previously: coronary artery bypass grafting (CABG)

Outcome Measures

Primary Outcome Measures :

Rate of Graft Patency [ Time Frame: after the primary CABG (until June the 30th 2020) ]
Grade of freedom from stenosis in the saphenous vein graft used during the primary CABG

Secondary Outcome Measures :

Rate of MACE [ Time Frame: after the primary CABG (until June the 30th 2020) ]
major adverse cardiac events

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All the subjects that previously were operated with a coronary artery bypass grafting at the Cardiothoracic department of the University hospital of Orebro (from1992 until June 30th 2020) and that underwent a percutaneous coronary intervention in a venous graft between January the 1st, 2006 and June the 30th, 2020.

Criteria

Inclusion Criteria:

Angina after CABG requiring diagnostic coronary angiography
CABG operation between 1992 and June 30th 2020
Coronary angiography between 2006 and June 30th 2020

Exclusion Criteria:

Coronary angiography within 30 days from the CABG operation date

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656366

Locations

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Sweden
Kärl-Thoraxkliniken; University Hospital of Örebro	Recruiting
Örebro, Sweden, 70185
Contact: Gabriele Ferrari, MD +46196025267 gabriele.ferrari@regionorebrolan.se
Contact: Domingos Souza, MD; PhD +46196025204 domingos.ramos-de-souza@regionorebrolan.se
Principal Investigator: Gabriele Ferrari, MD

Sponsors and Collaborators

Region Örebro County

More Information

Publications:

Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4.

Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95.

Souza DS, Johansson B, Bojö L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8.

Samano N, Geijer H, Bodin L, Arbeus M, Mannion JD, Dashwood M, Souza D. The no-touch saphenous vein graft in elderly coronary bypass patients with multiple comorbidities is a promising conduit to substitute the left internal thoracic artery. J Thorac Cardiovasc Surg. 2017 Aug;154(2):457-466.e3. doi: 10.1016/j.jtcvs.2017.03.048. Epub 2017 Mar 24.

Bourassa MG. Fate of venous grafts: the past, the present and the future. J Am Coll Cardiol. 1991 Apr;17(5):1081-3.

Hindnavis V, Cho SH, Goldberg S. Saphenous vein graft intervention: a review. J Invasive Cardiol. 2012 Feb;24(2):64-71. Review.

Goldman S, Zadina K, Moritz T, Ovitt T, Sethi G, Copeland JG, Thottapurathu L, Krasnicka B, Ellis N, Anderson RJ, Henderson W; VA Cooperative Study Group #207/297/364. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004 Dec 7;44(11):2149-56.

Lee MS, Park SJ, Kandzari DE, Kirtane AJ, Fearon WF, Brilakis ES, Vermeersch P, Kim YH, Waksman R, Mehilli J, Mauri L, Stone GW. Saphenous vein graft intervention. JACC Cardiovasc Interv. 2011 Aug;4(8):831-43. doi: 10.1016/j.jcin.2011.05.014. Review.

Stone GW, Goldberg S, O'Shaughnessy C, Midei M, Siegel RM, Cristea E, Dangas G, Lansky AJ, Mehran R. 5-year follow-up of polytetrafluoroethylene-covered stents compared with bare-metal stents in aortocoronary saphenous vein grafts the randomized BARRICADE (barrier approach to restenosis: restrict intima to curtail adverse events) trial. JACC Cardiovasc Interv. 2011 Mar;4(3):300-9. doi: 10.1016/j.jcin.2010.11.013.

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Responsible Party:	Gabriele Ferrari, Principal Investigator, Region Örebro County
ClinicalTrials.gov Identifier:	NCT04656366
Other Study ID Numbers:	OLL-274418
First Posted:	December 7, 2020 Key Record Dates
Last Update Posted:	December 8, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Gabriele Ferrari, Region Örebro County:


vein graft no-touch angina coronary angiography graft patency

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