Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05406284

DK Nano-Culotte Stenting For Coronary Bifurcation Lesion

A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting

Status
Recruiting
Phase
Study type
Observational
Enrollment
12 (estimated)
Sponsor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Other Government
Sex
All
Age
18 Years – 90 Years
Healthy volunteers

Summary

True coronary bifurcation lesions are still great of interest due to their complex anatomy, uncertainty of optimal stenting strategy and increased adverse cardiovascular outcomes. Provisional stenting is recommended in patients with non-complex coronary lesions while 2-stent strategies should be considered in complex coronary bifurcation lesions. However, optimal 2-stent strategy is still controversial. Double kissing (DK) crush stenting is the prominent technique in true bifurcation lesion, especially in patients with left main coronary artery disease. DK mini-culotte stenting, increasing use in clinical practice, has become popular over DK crush stenting. It was demonstrated in a bench test that stent malapposition was lower in the DK mini-culotte stenting compared to the DK crush technique. Thus, DK mini-culotte stenting may be preferred over DK crush stenting in complex true coronary bifurcation lesion. On the other hand, it was demonstrated in previous studies, less than minimal protrusion (generally called as nano protrusion) had better clinical outcomes. Kawasaki et al was first demonstrated the minimal (nano) protrusion of culotte stenting technique. Then, Toth et al revealed a novel modified culotte stenting technique named single string culotte. There was no major adverse cardiac events (MACE) in patients underwent single string stenting technique with a median follow-up period of 6±4 months. Unsurprisingly there was no MACE occurred in patients who underwent Szabo 2-stent technique. In the light of foregoing data, the least possible amount of protrusion is known to have the best results. In addition to this, double kissing balloon dilatation with culotte stenting technique seems to have better results than other stenting techniques. In our study, we aimed to evaluate the angiographic and clinical results of a novel DK Nano-Culotte stenting in coronary bifurcation lesion.

Conditions

Interventions

TypeNameDescription
PROCEDUREdouble kissing nano culotte stentingpatients with true coronary bifurcation lesion treating with double kissing nano culotte stunting technique

Timeline

Start date
2024-07-01
Primary completion
2026-07-15
Completion
2026-12-30
First posted
2022-06-06
Last updated
2026-03-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05406284. Inclusion in this directory is not an endorsement.