NCT03714750Completed
Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. Further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. Recent randomized data demonstrate the superiority of the technique called double kissing and crush (DK-Crush) over provisional stenting in this setting. The DK-Crush technique is however cumbersome, time-consuming and requires very experienced operators. The investigators therefore plan to undertake a randomized study comparing a novel interventional technique against DK-crush in the setting of true bifurcation lesions (Medina lesions type 1,1,1 or 0,1,1).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 4 Oct 2018
- Start date
- 30 Oct 2018
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- Tommaso Gori
- Diseases
- Coronary artery disease
- NCT number
- NCT03714750
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 30 Oct 2018 to the primary completion date, 1 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another investigational drug or device study
Other illness
- History of stenting in target bifurcation lesion
Other
- Cardiogenic shock
- Trifurcation if all vessels are ≥2.75mm diameter
- Either bifurcation vessel not suitable for stenting
- Patient unable to give informed consent
- Women of child-bearing potential or lactating
- In-stent restenosis
Who the study is looking for
- Patients must meet all of the inclusion criteria:
- Documented heart team (as per guidelines) decision for revascularization via PCI
- Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches \>2.5mm and with a stenosis \>50% and clinical indication to percutaneous intervention, including:
- Ischemic symptoms, OR
- Positive non-invasive imaging for ischemia, OR
- Positive Flow Fractional Reserve (FFR), OR
- mean lumen area (MLA) \<6mm\^2 for the left main or \<4mm\^2 for epicardial vessels as assessed by intracoronary imaging (IVUS, OCT)
- Vessel diameter ≤5.00mm
- True bifurcation lesion type 1,1,1 or 0,1,1
- Patient ≥18 years old
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center of Cardiology, Cardiology I, university hospital Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.