Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions

NCT05872074 | Unknown

• 1 other identifier: CardioAinShams
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

● the investigators aims to study the impact of using drug coated balloon in coronary artery bifurcation lesions on the procedural success rate \& short-term MACE.

Conditions

Ischemia; Heart; Stents

Outcome Measures

Primary Outcomes (1)

• MACE (Number of participants complains of one of MACE )

  Primary end point target is 6-month follow-up for:- o MACEs (major adverse cardiac events) defined as :- 1. Death. (Measured as death or No death) 2. Non-fatal myocardial infarction (defined according to ESC guidelines as the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia ). Measured as occurrence of events or not 3. Target lesion re-vascularization (TLR) "defined as any clinically driven intervention (surgical or percutaneous) to the target lesion or any segment of the epicardial coronary artery containing the target lesion". Measured as need of revascularization by percutenous coronary intervention or coronary artery bypass grafting or not 4. Stroke (loss of blood flow to part of the brain, which damages brain tissue transiently or permanently approved by clinical symptoms and imaging ( confirmed by CT or MRI) measured by occurrence of stroke or not

  6 monthes

Secondary Outcomes (1)

• Lesion and procedure

  6 monthes

Study Arms (2)

Conventional balloon

NO INTERVENTION

patients Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty wire both branches, MV and SB, with two coronary guide wires. Main branch pre-dilation Side branch pre-dilation using ordinary balloon for the side branch) Main vessel stenting Proximal optimization technique (POT) of the main vessel stent

Drug coated balloon

EXPERIMENTAL

patients Who will undergo provisional stenting using Drug coated balloon (paclitaxel-coated balloon (PCB)) wire both branches, main vessel and side branch, with two coronary guide wires. Main branch pre-dilation Side branch pre-dilation using Drug coated balloon (paclitaxel-coated balloon for the side branch Main vessel stenting Proximal optimization technique (POT) of the main vessel stent

Diagnostic Test: Coronary angiography plus percutenous coronary intervention

Interventions

Coronary angiography plus percutenous coronary intervention DIAGNOSTIC_TEST

1. wire both branches, MV and SB, with two coronary guide wires. 2. Main branch pre-dilation 3. Side branch pre-dilation using (ordinary balloon in group "A" and Drug coated balloon in group "B" for the side branch) 4. Main vessel stenting 5. Proximal optimization technique (POT) of the main vessel stent

Drug coated balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age above 18 years indicated for elective coronary angiography according to ESC 2018 guidelines with a bifurcation lesion affected Side branch (SB)
• Patient Who planned for provisional stenting technique from the start or shifted to 2-stent strategy as a bailout to the Side branch
• Bifurcation lesion with medina classification (1,1,1), (1,0,1) and (0,1,1)

You may not qualify if:

• Medina classification (1,1,0) or (0,1,0) or (1,0,0)
• Side branch less than 2 mm in diameter
• Patients who have multiple lesions with high syntax score and clinical characteristics favoring coronary artery bypass grafting according to latest ESC guidelines 2018.
• Need for concomitant valvular surgery

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams university , Faculty of Medicine

Cairo, 002, Egypt

RECRUITING

Related Publications (12)

• Behan MW, Holm NR, de Belder AJ, Cockburn J, Erglis A, Curzen NP, Niemela M, Oldroyd KG, Kervinen K, Kumsars I, Gunnes P, Stables RH, Maeng M, Ravkilde J, Jensen JS, Christiansen EH, Cooter N, Steigen TK, Vikman S, Thuesen L, Lassen JF, Hildick-Smith D. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J. 2016 Jun 21;37(24):1923-8. doi: 10.1093/eurheartj/ehw170. Epub 2016 May 8.

  PMID: 27161619 BACKGROUND

• Bukka M, Rednam PJ, Sinha M. Drug-eluting balloon: design, technology and clinical aspects. Biomed Mater. 2018 Feb 23;13(3):032001. doi: 10.1088/1748-605X/aaa0aa.

  PMID: 29227279 BACKGROUND

• 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.

  PMID: 20194880 BACKGROUND

• Cortese B, Bertoletti A. Paclitaxel coated balloons for coronary artery interventions: a comprehensive review of preclinical and clinical data. Int J Cardiol. 2012 Nov 1;161(1):4-12. doi: 10.1016/j.ijcard.2011.08.855. Epub 2011 Sep 28.

  PMID: 21955612 BACKGROUND

• Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.

  PMID: 32473887 BACKGROUND

• Khan MA, Hashim MJ, Mustafa H, Baniyas MY, Al Suwaidi SKBM, AlKatheeri R, Alblooshi FMK, Almatrooshi MEAH, Alzaabi MEH, Al Darmaki RS, Lootah SNAH. Global Epidemiology of Ischemic Heart Disease: Results from the Global Burden of Disease Study. Cureus. 2020 Jul 23;12(7):e9349. doi: 10.7759/cureus.9349.

  PMID: 32742886 BACKGROUND

• Wilensky RL, Selzer F, Johnston J, Laskey WK, Klugherz BD, Block P, Cohen H, Detre K, Williams DO. Relation of percutaneous coronary intervention of complex lesions to clinical outcomes (from the NHLBI Dynamic Registry). Am J Cardiol. 2002 Aug 1;90(3):216-21. doi: 10.1016/s0002-9149(02)02457-8.

  PMID: 12127606 BACKGROUND

• Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.

  PMID: 22386286 BACKGROUND

• Niemela M, Kervinen K, Erglis A, Holm NR, Maeng M, Christiansen EH, Kumsars I, Jegere S, Dombrovskis A, Gunnes P, Stavnes S, Steigen TK, Trovik T, Eskola M, Vikman S, Romppanen H, Makikallio T, Hansen KN, Thayssen P, Aberge L, Jensen LO, Hervold A, Airaksinen J, Pietila M, Frobert O, Kellerth T, Ravkilde J, Aaroe J, Jensen JS, Helqvist S, Sjogren I, James S, Miettinen H, Lassen JF, Thuesen L; Nordic-Baltic PCI Study Group. Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III. Circulation. 2011 Jan 4;123(1):79-86. doi: 10.1161/CIRCULATIONAHA.110.966879. Epub 2010 Dec 20.

  PMID: 21173348 BACKGROUND

• Niccoli G, Ferrante G, Porto I, Burzotta F, Leone AM, Mongiardo R, Mazzari MA, Trani C, Rebuzzi AG, Crea F. Coronary bifurcation lesions: to stent one branch or both? A meta-analysis of patients treated with drug eluting stents. Int J Cardiol. 2010 Feb 18;139(1):80-91. doi: 10.1016/j.ijcard.2008.10.016. Epub 2008 Nov 22.

  PMID: 19027969 BACKGROUND

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534. doi: 10.4244/EIJY19M01_01. No abstract available.

  PMID: 30667361 BACKGROUND

• Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES. Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study. PLoS One. 2016 Jan 29;11(1):e0147057. doi: 10.1371/journal.pone.0147057. eCollection 2016.

  PMID: 26824602 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Officials

• Ahmed Hassan, MSc

  Ain shams university , cardiology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Hassan, MSc

CONTACT

01002464361; Am.hassan88@gmail.com

Yousef Amin, MD

CONTACT

01001737008; Yousef.amin23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 24, 2023
• Study Start: October 4, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

EG (1)