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| Name | Class |
|---|---|
| Golden Jubilee National Hospital | OTHER_GOV |
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Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts.
It has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion PCI are of shorter duration, could improve safety and efficacy.
The investigators hypothesize that
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invest CTO PCI | Experimental | A pre-planned two staged procedure in high-risk CTO PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronic total occlusion(CTO) percutaneous coronary intervention (PCI) | Procedure | CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | CTO PCI Procedural success, Complete technical success plus the absence of an in-hospital major adverse cardiovascular event (MACE; death, MI, or clinically driven target vessel revascularization [TVR] | Up to 12 weeks |
| Compositie safety endpoint | Death, myocardial infarction and procedural related complications | 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| CTO PCI technical success | Technical success is restoration of TIMI >=2 antegrade flow with <30% residual diameter stenosis within the CTO segment | At the end of staged CTO PCI completion procedure and within 3 months |
| CTO PCI investment procedural success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret B Mcentegart, PhD | Golden Jubilee National Hospital | Principal Investigator |
| Anja Ćksnes, MD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center/ NewYork Presbyterian Hospital | New York | New York | 10032 | United States | ||
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Prospective, single arm, international, multicenter study
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Investment complete technical success |
| 30 days post procedure |
| Compositie safety endpoint | Death, myocardial infarction and procedural related complications | 30 days post procedure |
| Composite Clinical endpoint | Cardiac death, MI , cardiovascular hospitalization and target vessel revascularization. | 30 days, 3 & 12 months |
| European Quality of Life-5 Dimensions | 5 item measure of mobility, self-care, usual activity, pain or discomfort, and anxiety or depression . Score 0-100, where high score better. | Baseline, 3 and 12 months |
| Seattle angina questionnaire (SAQ7) | 3 domain score of physical limitation (SAQ7-PL), angina frequency (SAQ7-AF) and quality of life (SAQ7-QL). Score 0-100, where high score better. | Baseline, 3 & 12 months |
| Patient related outcome measures (PROM) | Qualitative interviews | Through study completion, an average of 15 months. |
| Haukeland University Hospital |
| Bergen |
| Bergen |
| 5021 |
| Norway |
| Golden Jubilee National Hospital | Glasgow | Glasgow | G814DY | United Kingdom |
| Bristol Health | Bristol | 06010 | United Kingdom |
| St George“s Hospital | London | SW 0QT | United Kingdom |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |