NCT07159737Toborzás még nem indult
Comparison of HYBRID Versus Two-Stent Strategies in Unprotected True Left MAIN Bifurcation
Comparison of Hybrid Versus Two-Stent Strategies in Patients With Unprotected True Left Main Coronary Artery Bifurcation Disease: A Streamlined, Multicentre, Investigator-Initiated, Randomized Superiority Trial (HYBRID MAIN)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 30.
Rövid összefoglaló (regiszter, angolul)
The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart. The most critical narrowing occurs in the left main coronary artery (LMCA), which supplies blood to over two-thirds of the heart muscle. Treating this narrowing is essential to prevent heart attacks or death. The LMCA divides into two branches, known as a bifurcation, both of which require treatment if narrowed. Currently, narrowing in both branches-the left anterior descending artery (LAD) and the left circumflex artery (LCx)-is treated with a two-stent strategy, where metallic stents are placed in each branch to keep the arteries open. However, this approach is prone to re-narrowing, particularly at the origin of the LCx. A new procedure, called the hybrid strategy, offers an alternative. It involves placing one stent in the LMCA and LAD while inflating a special balloon in the LCX. This balloon, known as a drug-coated balloon, releases a chemical that reduces narrowing over time without needing a stent. At present, there is uncertainty which strategy is better. This study will assess whether the hybrid strategy is more effective than the two-stent strategy in preventing death, heart attacks, and re-narrowing of the arteries. Participants will have an equal chance of receiving either the two-stent or hybrid strategy and will only join the study if their doctor is unsure which method is best. To minimise the burden on participants, all study procedures and follow-ups will be integrated into standard routine care. The results of this study have the potential to offer a new, safer treatment that could save the lives of millions of people with this condition.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 800 (tervezett)
- Első benyújtás
- 2025. aug. 21.
- Kezdés
- 2026. jan. 1.
- Elsődleges befejezés
- 2028. jan. 1.
- Fő szponzor
- Hospital Sultanah Bahiyah
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07159737
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 800
- 2026. jan. 1. és az elsődleges befejezés (2028. jan. 1.) között
- Nincs megadott helyszín, ország nélkül
- 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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Korábbi kezelés
- Contraindication to antiplatelet therapy or study devices
Egyéb
- Protected left main (patent graft to LAD and LCX)
- Need for anticoagulation
- LCx reference vessel diameter less than 2.5 mm (< 2.5 mm)
- Cardiogenic shock
- Severe left ventricular (LV) dysfunction making either strategy unsafe
- Life expectancy less than 2 years
- Participation in another trial that may affect results
Kiket keres a vizsgálat
- Floating eligibility criteria
- De novo unprotected true left main bifurcation (UTLMB) (Medina 1,1,1; 1,0,1; and 0,1,1).
- Optimal LCx lesion preparation (residual stenosis less than 30% with absence of flow-limiting dissection).
- The operator feels it might be appropriate to place either a drug-eluting stent (DES) or drug-coated balloon (DCB) to the LCX
- Clinically stable at the time of randomisation.
- Able to complete 2-year follow-up.
- Able to complete dual antiplatelet therapy (DAPT) as per guidelines.
- Written informed consent (or verbal consent on-table with written consent as soon as possible thereafter).
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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