Percutaneous Coronary InterventionNCT03999398
Short and Long-term Results of PCI in no Touch Vein-graft.
An observational study of Percutaneous Coronary Intervention and Saphenous Vein, run by Region Örebro County at 1 site in Sweden.
Trial summary
Coronary artery disease is one of the biggest health issue worldwide.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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Percutaneous Coronary Intervention, Saphenous Vein, Coronary Artery Bypass
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2017to 2 Jan 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 (from the 1992 until 30th June 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
- Participants previously operated with a coronary artery bypass grafting at the Cardiothoracic department of the University hospital of Orebro
- Participants that underwent a percutaneous coronary intervention in a venous graft
Who cannot join
- percutaneous coronary intervention within 30 days from the primary operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long-term Results of PCI in no Touch Vein-graft:a Comparison With the Standard One.
Coronary artery disease is one of the biggest health issue worldwide.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 year.
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).
Read more
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 analyse all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). All the patients who received a stent during the post-operative angiography will be analysed in detail and one will compare the occlusion grade and the rate of major adverse cardiac events (MACE).
This study is the first and the only one in the world that will examine the long-term results of the no-touch technique in particular after the stenting of the venous graft.
Read the detailed description
The study is a observational retrospective with registered-based data. The register used is Swedeheart which is the national Swedish intervention-related quality register for cardiological interventions (such as percutaneous coronary intervention (PCI)) and cardiac surgical procedures that are performed every year in Sweden.
After the approval of the Regional ethical review board in Uppsala (Sweden), one could review all the subjects that received a PCI in a venous graft between January the 1st, 2006 and June the 30th, 2020 either at the Angiographic unit of the University Hospital of Orebro or at the Angiographic unit of the Hospital of Karlstad. All the participants has been previously operated at the Cardiothoracic department of the University hospital of Orebro with a coronary artery bypass grafting (CABG) procedure, with one type of vein graft (no-touch) or the other (standard) All the relevant data for the study that are missed in the quality register, are extrapolated by the clinical registers of the two hospital involved (Orebro and Karlstad).
Once finished the data extraction and review, the data will be statistically analysed in term of short and long term results; and an advanced comparison between the two different type of venous graft involved. This is to show if there is a significant difference between the two techniques also after a PCI procedure (already proven clinical different between the two technique in favour of the no-touch one by numerous studies).
Moreover an assessment of the patients´ quality of life in the two different studies will be performed with the use of Health related quality of life surveys (RAND-36); even a health economics analysis will be preformed (QALY).
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- Saphenous Vein, No-touch, Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
Also called Previously: coronary artery bypass grafting (CABG)
Participants are treated with a PCI and stent implantation in a venous graft (previously implanted during the CABG operation)
| 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: Procedure: Percutaneous coronary intervention (PCI) | |
| Conventional | Participants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft. Receives: Procedure: Percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of In-stent restenosis
stenosis or occlusion of the stent implanted during the percutaneous coronary intervention procedurerevascularisation)
Measured: after the percutaneous coronary intervention (until December the 01st 2020)
Secondary outcomes (3)
Rate of Major adverse cardiac event (MACE)
adverse cardiac event (mortality (cardiac) + myocardial infarction + target vessel
Measured: after the percutaneous coronary intervention (until December the 01st 2020)
Quality of life (RAND-36)
health related quality of life surveys assessment; reporting a score on a scale,the minimum value is 0 and the maximum value is 100; higher scores mean a better outcome
Measured: after the percutaneous coronary intervention, through study completion, an average of 5 years
QALY (quality-adjusted life-year)
health economics analysis
Measured: after the percutaneous coronary intervention, through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Oct 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion2 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies 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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Karlstad Central Hospital
- Responsible party
- Principal investigator, Gabriele Ferrari, Region Örebro County
- Investigators
- Gabriele Ferrari, MD, Principal investigator, Region Örebro län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999398
- Sponsor's protocol ID
- OLL-242381
- Status last verified
- Mar 2021
- First submitted
- 24 Jun 2019
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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, Bodin L, Karlsson J, Geijer H, Arbeus M, Souza D. Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):388-394. doi: 10.1093/icvts/ivw372.
PubMed 28040753Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.
PubMed 26282605Bourassa 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 2007707Campeau L, Enjalbert M, Lesperance J, Bourassa MG, Kwiterovich P Jr, Wacholder S, Sniderman A. The relation of risk factors to the development of atherosclerosis in saphenous-vein bypass grafts and the progression of disease in the native circulation. A study 10 years after aortocoronary bypass surgery. N Engl J Med. 1984 Nov 22;311(21):1329-32. doi: 10.1056/NEJM198411223112101.
PubMed 6333635Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
PubMed 8772748Hindnavis 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 21851895Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.
PubMed 21872918Stone 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, Geijer H, Cao Y, Graf U, Bojo L, Carlsson R, Souza D, Samano N. Long-term results of percutaneous coronary intervention in no-touch vein grafts are significantly better than in conventional vein grafts. Perfusion. 2025 Jan;40(1):211-220. doi: 10.1177/02676591241230012. Epub 2024 Jan 22.
PubMed 38253348
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Results of PCI in no Touch Vein-graft:a Comparison With the Standard One.
- ClinicalTrials.gov ID
- NCT03999398
- Acronym / sponsor ID
- OLL-242381
- Keywords
- Saphenous Vein, No-touch, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Karlstad Central Hospital
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 2 Jan 2022 (estimated)
- First posted
- 26 Jun 2019 (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.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 year.
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).
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 analyse all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). All the patients who received a stent during the post-operative angiography will be analysed in detail and one will compare the occlusion grade and the rate of major adverse cardiac events (MACE).
This study is the first and the only one in the world that will examine the long-term results of the no-touch technique in particular after the stenting of the venous graft.
Detailed description
The study is a observational retrospective with registered-based data. The register used is Swedeheart which is the national Swedish intervention-related quality register for cardiological interventions (such as percutaneous coronary intervention (PCI)) and cardiac surgical procedures that are performed every year in Sweden.
After the approval of the Regional ethical review board in Uppsala (Sweden), one could review all the subjects that received a PCI in a venous graft between January the 1st, 2006 and June the 30th, 2020 either at the Angiographic unit of the University Hospital of Orebro or at the Angiographic unit of the Hospital of Karlstad. All the participants has been previously operated at the Cardiothoracic department of the University hospital of Orebro with a coronary artery bypass grafting (CABG) procedure, with one type of vein graft (no-touch) or the other (standard) All the relevant data for the study that are missed in the quality register, are extrapolated by the clinical registers of the two hospital involved (Orebro and Karlstad).
Once finished the data extraction and review, the data will be statistically analysed in term of short and long term results; and an advanced comparison between the two different type of venous graft involved. This is to show if there is a significant difference between the two techniques also after a PCI procedure (already proven clinical different between the two technique in favour of the no-touch one by numerous studies).
Moreover an assessment of the patients´ quality of life in the two different studies will be performed with the use of Health related quality of life surveys (RAND-36); even a health economics analysis will be preformed (QALY).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-touch | – | Procedure: Percutaneous coronary intervention (PCI)Participants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft. |
| Conventional | – | Procedure: Percutaneous coronary intervention (PCI)Participants 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 (from the 1992 until 30th June 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 (2 listed)
- Participants previously operated with a coronary artery bypass grafting at the Cardiothoracic department of the University hospital of Orebro
- Participants that underwent a percutaneous coronary intervention in a venous graft
Key exclusion criteria (1 listed)
- percutaneous coronary intervention within 30 days from the primary operation
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 |
|---|---|---|
| Percutaneous coronary intervention (PCI)Also: Previously: coronary artery bypass grafting (CABG)Participants are treated with a PCI and stent implantation in a venous graft (previously implanted during the CABG operation) | Procedure or surgery | Conventional, No-touch |
Primary outcome
Rate of In-stent restenosis
Time frame: after the percutaneous coronary intervention (until December the 01st 2020)
stenosis or occlusion of the stent implanted during the percutaneous coronary intervention procedurerevascularisation)
3 secondary outcomes
Rate of Major adverse cardiac event (MACE)
Time frame: after the percutaneous coronary intervention (until December the 01st 2020)
Quality of life (RAND-36)
Time frame: after the percutaneous coronary intervention, through study completion, an average of 5 years
QALY (quality-adjusted life-year)
Time frame: after the percutaneous coronary intervention, through study completion, an average of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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 28040753Samano N, Bodin L, Karlsson J, Geijer H, Arbeus M, Souza D. Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):388-394. doi: 10.1093/icvts/ivw372.
- Background: PubMed 26282605Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.
- 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 6333635Campeau L, Enjalbert M, Lesperance J, Bourassa MG, Kwiterovich P Jr, Wacholder S, Sniderman A. The relation of risk factors to the development of atherosclerosis in saphenous-vein bypass grafts and the progression of disease in the native circulation. A study 10 years after aortocoronary bypass surgery. N Engl J Med. 1984 Nov 22;311(21):1329-32. doi: 10.1056/NEJM198411223112101.
- Background: PubMed 8772748Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
- 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 21872918Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.
- link of the original (Swedish) project planLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Gabriele Ferrari, MD principal investigator
Region Örebro län
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 Percutaneous Coronary Intervention and Saphenous Vein, 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 2 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 9 Mar 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of In-stent restenosis (time frame: after the percutaneous coronary intervention (until December the 01st 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 NCT03999398, which also lists 14 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 9 Mar 2021.