- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406284
DK Nano-Culotte Stenting For Coronary Bifurcation Lesion
March 4, 2024 updated by: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
A Novel Coronary Bifurcation Stenting Technique With Minimal Protrusion: Double Kissing Nano-Culotte Stenting
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Serkan Kahraman, Assoc Prof
- Phone Number: +905053825921
- Email: serkankahraman_86@outlook.com
Study Locations
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-
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Istanbul, Turkey, 34303
- Istanbul Mehmet Akif Ersoy Training and Research Hospital
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Contact:
- Serkan Kahraman, MD
- Phone Number: +905053825921
- Email: serkankahraman_86@outlook.com
-
Principal Investigator:
- Serkan Kahraman, MD
-
Sub-Investigator:
- Mehmet Erturk, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Patients with stable or unstable angina pectoris or patients with non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention and performing DK nano culotte stunting technique
Description
Inclusion Criteria:
- Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
- The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm
Exclusion Criteria:
- Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
- Patients with a history of coronary artery bypass grafting surgery
- Patients with a chronic total occlusion in the bifurcation area
- Lesions with severe calcification that needs additional intervention such as atherectomy
- Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
- Patients with hematological disorders, malignancy, end stage renal (GFR<30 ml/min) and hepatic failure
- Patients with active bleeding
- Pregnant women
- Patients with life-expectancy < 1 year
- Patients treated with small open cell stent platforms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
double kissing nano culotte stenting
|
patients with true coronary bifurcation lesion treating with double kissing nano culotte stunting technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE (major adverse cardiovascular events)
Time Frame: 6 months
|
target vessel revascularization, myocardial infarction or cardiac death
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACCE (major adverse cerebral and cardiovascular events)
Time Frame: 6, 12 months
|
all cause death, myocardial infarction, target vessel revascularization, in-stent thrombosis/restenosis or stroke
|
6, 12 months
|
target lesion failure
Time Frame: 6, 12 months
|
target lesion revascularization, myocardial infarction, cardiac death
|
6, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23.
- Ferenc M, Gick M, Kienzle RP, Bestehorn HP, Werner KD, Comberg T, Kuebler P, Buttner HJ, Neumann FJ. Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J. 2008 Dec;29(23):2859-67. doi: 10.1093/eurheartj/ehn455. Epub 2008 Oct 9.
- Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.
- Chen SL, Zhang JJ, Han Y, Kan J, Chen L, Qiu C, Jiang T, Tao L, Zeng H, Li L, Xia Y, Gao C, Santoso T, Paiboon C, Wang Y, Kwan TW, Ye F, Tian N, Liu Z, Lin S, Lu C, Wen S, Hong L, Zhang Q, Sheiban I, Xu Y, Wang L, Rab TS, Li Z, Cheng G, Cui L, Leon MB, Stone GW. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. J Am Coll Cardiol. 2017 Nov 28;70(21):2605-2617. doi: 10.1016/j.jacc.2017.09.1066. Epub 2017 Oct 30.
- Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation. 2009 Jan 6;119(1):71-8. doi: 10.1161/CIRCULATIONAHA.108.808402. Epub 2008 Dec 22.
- Toth GG, Sasi V, Franco D, Prassl AJ, Di Serafino L, Ng JCK, Szanto G, Schneller L, Ang HY, Plank G, Wijns W, Barbato E. Double-kissing culotte technique for coronary bifurcation stenting. EuroIntervention. 2020 Oct 9;16(9):e724-e733. doi: 10.4244/EIJ-D-20-00130.
- Kawasaki T, Koga H, Serikawa T. Modified culotte stenting technique for bifurcation lesions: the cross-stenting technique. J Invasive Cardiol. 2010 May;22(5):243-6.
- G Toth G, Pyxaras S, Mortier P, De Vroey F, Di Gioia G, Adjedj J, Pellicano M, Ferrara A, De Schryver T, Van Hoorebeke L, Verhegghe B, Barbato E, De Bruyne B, De Beule M, Wijns W. Single String Technique for Coronary Bifurcation Stenting: Detailed Technical Evaluation and Feasibility Analysis. JACC Cardiovasc Interv. 2015 Jun;8(7):949-59. doi: 10.1016/j.jcin.2015.01.037. Epub 2015 May 20.
- Yang H, Qian J, Huang Z, Ge J. Szabo 2-stent technique for coronary bifurcation lesions: procedural and short-term outcomes. BMC Cardiovasc Disord. 2020 Jul 7;20(1):325. doi: 10.1186/s12872-020-01605-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
August 15, 2024
Study Completion (Estimated)
August 30, 2025
Study Registration Dates
First Submitted
June 1, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMAEETH-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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