DK Nano-Culotte Stenting For Coronary Bifurcation Lesion

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05406284
• Other study ID #: IMAEETH-3
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: March 2024
• Source: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
• Contact: Serkan Kahraman, Assoc Prof
• Phone: +905053825921
• Email: serkankahraman_86[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: August 30, 2025
• Est. primary completion date: August 15, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• double kissing nano culotte stenting
patients with true coronary bifurcation lesion treating with double kissing nano culotte stunting technique

Locations

Country	Name	City	State
Turkey	Istanbul Mehmet Akif Ersoy Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (major adverse cardiovascular events)	target vessel revascularization, myocardial infarction or cardiac death	6 months
Secondary	MACCE (major adverse cerebral and cardiovascular events)	all cause death, myocardial infarction, target vessel revascularization, in-stent thrombosis/restenosis or stroke	6, 12 months
Secondary	target lesion failure	target lesion revascularization, myocardial infarction, cardiac death	6, 12 months