NCT06280638Befejeződött
CT-derived Virtual Stenting Optimize Coronary Revascularization (CT-COMPASS)
Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients With Coronary Artery Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 12.
Rövid összefoglaló (regiszter, angolul)
A considerable number of patients presented with anatomically successful PCI results still suffer from functionally unresolved ischemia, which might be the cause for over one-fourth of patients experiencing recurrent angina at 1 year or adverse events at 2 years. Currently, the post-PCI physiology measurement is one of the effective metrics to quantify residual ischemia, and a suboptimal post-PCI result is strongly associated with worse outcomes. However, PCI optimization based on post-PCI physiology is, to certain extent, a provisional rescue action for a suboptimal index procedure, which may not be fully correctable "after the fact" given selected stents, site of deployment and procedural technique. Computed tomography (CT) coronary physiology-derived virtual stenting (CT-VS) based on pre-PCI CCTA angiograms is an augmented reality (AR) approach that simulates the post-stenting physiology assuming that the specified segment of the treated vessel is successfully dilated by implanting virtual stents. Previous studies have demonstrated the feasibility of optimizing PCI with CT-VS, with high consistency between pre-PCI simulated physiology result by CT-VS and actual post-PCI physiology results. Therefore, the application of CT-VS would help physicians to develop the best strategies while planning the procedure. However, there is a lack of knowledge regarding the efficacy of this novel physiological index that is available pre-PCI in achieving final post-PCI optimal physiological result. The Trials of "Computed Tomography Coronary Physiology-derived Virtual Stenting Guided Revascularization Strategy in Patients with Coronary Artery Disease (CT-COMPASS)" was designed to assess the efficacy of a CT-VS vs. standard angiographic guidance in achieving post-PCI optimal physiological result (post-PCI FFR≥0.90).
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 280 (tényleges)
- Első benyújtás
- 2024. febr. 11.
- Kezdés
- 2024. márc. 5.
- Elsődleges befejezés
- 2025. jún. 23.
- Fő szponzor
- China National Center for Cardiovascular Diseases
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT06280638
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 280
- 2024. márc. 5. és az elsődleges befejezés (2025. jún. 23.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- Allergy to iodine-containing contrast agents which cannot be adequately premedicated.
- CCTA Exclusion Criteria
Laborértékek
- Cardiogenic shock or severe heart failure (NYHA ≥III or LVEF<30%).
- Severely impaired renal function: creatinine >150μmol/L or Cockcroft-Gault calculated GFR <45 ml/kg/1.73 m2 (calculated with Cockcroft-Gault formula).
Egyéb
- General Exclusion Criteria
- The CCTA angiograms deems not amenable to CT-FFR measurement.
- Patients with only 1 coronary artery lesion with DS >90% with TIMI flow <3.
- An interrogated vessel presented with a CTO lesion.
- All coronary arteries were not physiologically ischemic.
- Coronary lesions favor CABG treatment.
- Angiographic Exclusion Criteria
- The interrogated vessel with only 1 coronary artery lesion with DS >90% with TIMI flow <3.
- Coronary lesions favor CABG treatment.
Kiket keres a vizsgálat
- General Inclusion Criteria
- Age ≥ 18 years.
- Able to understand the trial design and provide written informed consent.
- Patients with a coronary CTA performed within 30 days.
- CCTA Inclusion Criteria
- The CCTA angiograms amenable to CT-FFR measurement.
- At least 1 lesion of 50%-90% diameter stenosis in a coronary artery with ≥2.0mm reference vessel diameter by visual assessment.
- And this target vessel is of physiological ischemia as assessed by CT-FFR.
- Angiographic Inclusion Criteria
- The interrogated vessel is indicated for intervention assessed by operator based on indications other than CT-FFR.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.