Percutaneous Coronary Intervention Clinical Trial
Official title:
Short and Long-term Results of PCI in no Touch Vein-graft:a Comparison With the Standard One.
Verified date | March 2021 |
Source | Region Örebro County |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 260 |
Est. completion date | January 2, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - percutaneous coronary intervention within 30 days from the primary operation |
Country | Name | City | State |
---|---|---|---|
Sweden | Kärl-Thoraxkliniken; University Hospital of Örebro | Örebro |
Lead Sponsor | Collaborator |
---|---|
Region Örebro County | Karlstad Central Hospital |
Sweden,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of Mortality | overall mortality after the procedure | after the percutaneous coronary intervention (until December the 01st 2020) | |
Primary | Rate of In-stent restenosis | stenosis or occlusion of the stent implanted during the percutaneous coronary intervention procedurerevascularisation) | after the percutaneous coronary intervention (until December the 01st 2020) | |
Secondary | Rate of Major adverse cardiac event (MACE) | adverse cardiac event (mortality (cardiac) + myocardial infarction + target vessel | after the percutaneous coronary intervention (until December the 01st 2020) | |
Secondary | 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 | after the percutaneous coronary intervention, through study completion, an average of 5 years | |
Secondary | QALY (quality-adjusted life-year) | health economics analysis | after the percutaneous coronary intervention, through study completion, an average of 5 years |
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