Bypass Graft StenosisNCT04656366
Results of Coronary Angiography Rafter CABG: Comparison Between No-touch and Conventional Vein Graft
An observational study of Bypass Graft Stenosis, run by Region Örebro County at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bypass Graft Stenosis
- What is being tested?
- Coronary Angiography
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2020to 1 Feb 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Angina after CABG requiring diagnostic coronary angiography
- CABG operation between 1992 and June 30th 2020
- Coronary angiography between 2006 and June 30th 2020
Who cannot join
- Coronary angiography within 30 days from the CABG operation date
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Kärl-Thoraxkliniken; University Hospital of Örebro
Örebro, 70185
Gabriele Ferrari, MD, +46196025267, gabriele.ferrari@regionorebrolan.se
Domingos Souza, MD; PhD, +46196025204, domingos.ramos-de-souza@regionorebrolan.se
About this study
Official title: Coronary Angiographical Results in Patients With Angina After CABG: Comparison Between No-touch and Conventional Vein Graft
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.
- Conditions
- Bypass Graft Stenosis
- Being tested
- Coronary Angiography
- Keywords
- vein graft, no-touch, angina, coronary angiography, graft patency
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyDiagnostic test
Also called Previously: coronary artery bypass grafting (CABG)
Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention)
| Study group | Role | What they receive |
|---|---|---|
| No-touch | Participants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft. Receives: Diagnostic Test: Coronary Angiography | |
| Conventional | Participants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft. Receives: Diagnostic Test: Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Graft Patency
Grade of freedom from stenosis in the saphenous vein graft used during the primary CABG
Measured: after the primary CABG (until June the 30th 2020)
Secondary outcomes (1)
Rate of MACE
major adverse cardiac events
Measured: after the primary CABG (until June the 30th 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Nov 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bypass Graft StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Ferrari, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656366
- Sponsor's protocol ID
- OLL-274418
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.
PubMed 8727856Souza 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. doi: 10.1016/s0003-4975(02)03425-2.
PubMed 11996262Souza DS, Johansson B, Bojo 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. doi: 10.1016/j.jtcvs.2006.04.002.
PubMed 16872965Samano 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.
PubMed 28433355Bourassa MG. Fate of venous grafts: the past, the present and the future. J Am Coll Cardiol. 1991 Apr;17(5):1081-3. doi: 10.1016/0735-1097(91)90835-w. No abstract available.
PubMed 2007707Hindnavis V, Cho SH, Goldberg S. Saphenous vein graft intervention: a review. J Invasive Cardiol. 2012 Feb;24(2):64-71.
PubMed 22294536Goldman 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. doi: 10.1016/j.jacc.2004.08.064.
PubMed 15582312Lee 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.
PubMed 21851895Stone 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.
PubMed 21435608Ferrari G, Loayza R, Azari A, Geijer H, Cao Y, Carlsson R, Bojo L, Samano N, Souza D. Superior long-term patency of no-touch vein graft compared to conventional vein grafts in over 1500 consecutive patients. J Cardiothorac Surg. 2024 Oct 1;19(1):570. doi: 10.1186/s13019-024-03057-3.
PubMed 39354611
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Angiographical Results in Patients With Angina After CABG: Comparison Between No-touch and Conventional Vein Graft
- ClinicalTrials.gov ID
- NCT04656366
- Acronym / sponsor ID
- OLL-274418
- Conditions
- Bypass Graft Stenosis
- Keywords
- vein graft, no-touch, angina, coronary angiography, graft patency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-touch | – | Diagnostic Test: Coronary AngiographyParticipants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft. |
| Conventional | – | Diagnostic Test: Coronary AngiographyParticipants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Angina after CABG requiring diagnostic coronary angiography
- CABG operation between 1992 and June 30th 2020
- Coronary angiography between 2006 and June 30th 2020
Key exclusion criteria (1 listed)
- Coronary angiography within 30 days from the CABG operation date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary AngiographyAlso: Previously: coronary artery bypass grafting (CABG)Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention) | Diagnostic test | Conventional, No-touch |
Primary outcome
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
1 secondary outcome
Rate of MACE
Time frame: after the primary CABG (until June the 30th 2020)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Background: PubMed 8727856Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.
- Background: PubMed 11996262Souza 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. doi: 10.1016/s0003-4975(02)03425-2.
- Background: PubMed 16872965Souza DS, Johansson B, Bojo 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. doi: 10.1016/j.jtcvs.2006.04.002.
- Background: PubMed 28433355Samano 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.
- Background: PubMed 2007707Bourassa MG. Fate of venous grafts: the past, the present and the future. J Am Coll Cardiol. 1991 Apr;17(5):1081-3. doi: 10.1016/0735-1097(91)90835-w. No abstract available.
- Background: PubMed 22294536Hindnavis V, Cho SH, Goldberg S. Saphenous vein graft intervention: a review. J Invasive Cardiol. 2012 Feb;24(2):64-71.
- Background: PubMed 15582312Goldman 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. doi: 10.1016/j.jacc.2004.08.064.
- Background: PubMed 21851895Lee 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.
- Background: PubMed 21435608Stone 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.
- Derived from this study: PubMed 39354611Ferrari G, Loayza R, Azari A, Geijer H, Cao Y, Carlsson R, Bojo L, Samano N, Souza D. Superior long-term patency of no-touch vein graft compared to conventional vein grafts in over 1500 consecutive patients. J Cardiothorac Surg. 2024 Oct 1;19(1):570. doi: 10.1186/s13019-024-03057-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kärl-Thoraxkliniken; University Hospital of Örebro
Örebro, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bypass Graft Stenosis, run by Region Örebro County at 1 site in Sweden.
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 3 inclusion and 1 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Graft Patency (time frame: after the primary CABG (until June the 30th 2020)). 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 NCT04656366, which also lists 10 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 8 Dec 2020.