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

Bypass Graft Stenosis Clinical Trial

Official title:

Coronary Angiographical Results in Patients With Angina After CABG: Comparison Between No-touch and Conventional Vein Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656366
• Other study ID #: OLL-274418
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: December 2020
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bypass Graft Stenosis

Intervention

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)

Locations

Country	Name	City	State
Sweden	Kärl-Thoraxkliniken; University Hospital of Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Graft Patency	Grade of freedom from stenosis in the saphenous vein graft used during the primary CABG	after the primary CABG (until June the 30th 2020)
Secondary	Rate of MACE	major adverse cardiac events	after the primary CABG (until June the 30th 2020)