Comparison of Double-kissing Crush and Double-kissing Culotte Stenting

Coronary Artery Disease Clinical Trial

Official title:

Comparison of Double-kissing Crush and Double-kissing Culotte Stenting in Patients With True Bifurcation Lesion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04789161
• Other study ID #: IMAEETH-2
• Status: Active, not recruiting
• Start date: March 4, 2021
• Est. completion date: May 4, 2024

Study information

• Verified date: April 2023
• Source: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy. Although the provisional stenting is still effective in suitable lesions, double stent techniques can be required in selected patients. In previous studies, double kissing crush (DK-crush) stenting was revealed as superior to provisional stenting in TBL of left main coronary artery. Additionally, in recent studies, double kissing approach facilitates and highlights double kissing culotte (DK-culotte) stenting with lower stent malapposition compared to DK-crush stenting. However, to the best of our knowledge, there is no study about comparing DK-crush and DK-culotte stenting in TBLs. Our aim in this study is to compare DK-crush and DK-culotte stenting in patients with TBL.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• double kissing crush stenting
Patients with true bifurcation lesion treating with double kissing crsuh stenting technique
• double kissing culotte stenting
Patients with true bifurcation lesion treating with double kissing culotte stenting 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 (5)

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, St — 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 coro — 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 versu — 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, Vir — 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-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	contrast induced nephropathy	25 percent (%) increase in serum creatinine level from baseline or a 0.5 mg/dL increase in absolute serum creatinine value within 72 hours after percutaneous coronary intervention	12 months
Primary	MACE (major adverse cardiovascular events)	target vessel revascularization, myocardial infarction and cardiac death	12 months
Secondary	MACCEs (major adverse cerebral and cardiovascular events)	all cause death, myocardial infarction, target lesion revascularization, target lesion revascularization, in-stent thrombosis and/or restenosis, stroke	12, 24, 36 months
Secondary	target lesion failure	myocardial infarction, cardiac death	24, 36 months