NCT07343076Toborzás még nem indult
Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE II)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 30.
Rövid összefoglaló (regiszter, angolul)
This is a prospective, multi-center, randomized controlled, open-label, blinded endpoint assessment study. The objective is to compare the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between two treatment strategies-immediate complete revascularization and staged complete revascularization-in NSTE-ACS patients with multivessel disease (MVD). NSTE-ACS patients who meet other the inclusion and exclusion criteria will be randomized into the following two groups after signing an informed consent form: Intervention group Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing). Control group During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1904 (tervezett)
- Első benyújtás
- 2026. jan. 6.
- Kezdés
- 2026. febr. 28.
- Elsődleges befejezés
- 2029. febr. 28.
- Fő szponzor
- RenJi Hospital
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07343076
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 1904
- 2026. febr. 28. és az elsődleges befejezés (2029. febr. 28.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Have received thrombolytic treatment.
- Previous PCI within the past 1 month or previous coronary artery bypass graft (CABG).
Más betegség
- Accompanied by other diseases that lead to an expected survival time of ≤ 12 months.
- Patients with severe valvular disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension.
- Not suitable for clinical study:
- Have enrolled in the other clinical studies that may affect the outcome assessment of this study.
- Pregnant and lactating women.
- Known allergy to the drugs that may be used in the study.
- Unable to comply with the trial protocol or follow-up requirements; or the investigator believes that participation in the trial may put the patient at greater risk.
Laborértékek
- Patients with other serious diseases such as severe renal insufficiency (creatinine clearance value <30ml/min), hepatic insufficiency, thrombocytopenia (≤50*109/L).
Egyéb
- Cardiogenic shock or SBP< 90 mmHg.
- Patients in whom the culprit vessel cannot be clearly identified.
- Left main coronary artery lesion, non-infarct-related arteries are CTO lesions or severely calcified lesions, complex lesions that require the use of special devices such as rotational ablation/laser.
Kiket keres a vizsgálat
- Age: 18 years or older.
- Patients with intermediate-to-high risk NSTE-ACS who meet the diagnostic criteria specified in current guideline, complicated by multivessel coronary artery disease, and have successfully undergone PCI for the culprit vessel.
- PCI within 72 hours of diagnosis.
- Accompanied by multivessel disease: defined as at least one non-culprit artery that meets the following conditions: a diameter of ≥2.5 mm by visual inspection, which can be successfully subjected to PCI, and the most severe diameter stenosis rate by visual inspection is at least 70% or positive coronary physiology testing.
- Sign an informed consent form before participating in the study.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.