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Ischemia; HeartDCBNCT05872074

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

A study testing Coronary angiography plus percutenous coronary intervention in people with Ischemia; Heart and Stents, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ischemia; Heart, Stents
What is being tested?
Coronary angiography plus percutenous coronary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
4 Oct 2023to 11 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Angiographical exclusion criteria as follows
  • 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

Trial locations and contacts

1 site in 1 country.

Ahmed M Hassan, MSc contact

01002464361 ext. 02

Am.hassan88@gmail.com

Yousef Amin, MD contact

01001737008

Yousef.amin23@gmail.com

Egypt1 site, 1 recruiting

  • Ainshams university , Faculty of Medicine

    Cairo, 002

    Yousef Amin, MD, 01001737008

    Recruiting

Other trials in Egypt

About this study

● 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.

Read the detailed description

Study Design:

A prospective study. Patients who met the inclusion criteria will be enrolled in our study will be subdivided into 2 groups :-

Group A: patient Who will undergo conventional provisional stenting using standard technique with plain balloon angioplasty Group B: patient Who will undergo provisional stenting using Drug coated balloon The patients will be randomly assigned for each group using a computer randomizing software application.

Both group with pass 3 stages: - Pre-procedural Interventional procedure Post -procedural Pre- procedural

History taking:

Age \& sex. Family history. Smoking status. Medical history including hypertension (HTN), diabetes mellitus (DM), renal impairment, etc.

Previous history of coronary artery disease, myocardial infarctions (MI), revascularization procedures Medical treatment and any significant history of allergy Previous intervention history regarding (site, type, diameter and length of the stent , complications and TIMI flow ) if available

General \&Physical examination:

with special emphasis on vital data, decubitus ,lung osculation and peripheral pulsation

Laboratory investigations:

Including kidney function, complete blood count, and High sensitive troponin in case of acute coronary syndrome Echocardiography will be done routinely for all patients with special emphasis on ejection fraction (to be assessed by modified Simpson's method), left ventricular dimensions, resting segmental wall motion abnormalities (RSWMAs).

Interventional procedure. Angiographic analysis. Serial coronary angiography will be performed at baseline (before and after intervention) and angiograms will be obtained in multiple views after intra-coronary nitrate if coronary spasm is suspected. coronary angiograms will be digitally recorded and analyzed by experienced personnel using a validated offline quantitative angiographic system and the following data will be collected: -

Bifurcation lesion distribution:

Left main artery bifurcation Left anterior descending artery/diagonal bifurcation Left circumflex artery/obtuse marginal bifurcation Right coronary artery/posterolateral branch

Medina classification the investigators will use Medina classification for coronary bifurcation lesion in which recording any narrowing more than 50% in each of the three arterial segments of the bifurcation in the following order: proximal main vessel (PMV). Distal main branch (DMV). Side branch (SB)

(1) is used to indicate the presence of a significant stenosis and (0) the absence of stenosis

Main vessel

Proximal reference diameter (mm) Distal reference diameter (mm) Mean reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%)) Lesion length (mm) Angiographic restenosis (%)

Side branch

Reference diameter (mm) Minimal lumen diameter (mm) Percentage diameter stenosis (%) Lesion length (mm)

Type of drug-eluting stents Sirolimus-eluting stents Everolimus-eluting stents Zotrolimus-eluting stents Biolimus A9-eluting stent Number of stent/drug-eluting balloon used Stent/drug-eluting balloon size (mm) Stent/drug-eluting balloon length (mm) Maximum balloon size (mm) Maximum inflation pressure (atmosphere) other coronary lesions

Intervention

  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

The following data will be recorded: -

  1. Inflation time (Seconds.)
  2. Inflation pressure (atmospheric pressure.)
  3. Diameter of the stent after inflation
  4. Time of the procedure After Intervention
  5. Reference luminal diameter (mm) 2) Minimal luminal diameter in stent (mm) 3) Minimal luminal diameter in lesion (mm) 4) lesion success (attainment of >50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis) 5) procedure success (attainment of a final lesion success and no major angiographic complications as dissection or perforation ).

Post-procedural Medications will be prescribed according to 2018 ESC myocardial revascularization guidelines.

Patients will be assessed for immediate outcomes:

lesion success attainment of >50% residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis procedure success attainment of a final lesion success and no major complication as :-

  1. Perforation with or without tamponade B. vascular access complications C. myocardial infarction D. contrast-induced nephropathy E. urgent coronary artery bypass grafting F. urgent repeat PCI G. Death.

Patients be assessed and monitor for 24 hours after the procedure and in the outpatient clinic after 6 months.

Follow up clinically after 6 months for MACEs

Study end points. Primary end point target is 6-month follow-up for:-

MACEs (major adverse cardiac events) defined as :-

  1. Death
  2. Non-fatal myocardial infarction
  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"
  4. Stroke

Improvement or recurrence of symptoms (chest pain and dyspnea) Symptomatic patients will undergo coronary angiography and those who has no symptoms with undergo functional assessment using either (High dose dobutamine echo or Myocardial perfusion imaging )

Secondary end points included:

lesion success procedure success

Being tested
Coronary angiography plus percutenous coronary intervention
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary angiography plus percutenous coronary interventionDiagnostic 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
Study groups in NCT05872074
Study groupRoleWhat they receive
Conventional balloonNo interventionpatients 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 balloonExperimentalpatients 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
Receives: Diagnostic Test: Coronary angiography plus percutenous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE (Number of participants complains of one of MACE )

    Primary end point target is 6-month follow-up for:-

    • 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

    Measured: 6 monthes

Secondary outcomes (1)

  1. Lesion and procedure

    lesion success (Measured by attainment of >50% in- stent residual stenosis of the target lesion, as measured by quantitative coronary angiographic analysis) Attainment >50 % = 0 For 10% to 50 % = 1 Less than 10% = 2

    • procedure success (Measured as attainment of a final lesion success > 50% and no major complications as dissection or perforation ) No complication = 0 Any major complication= 1 . Each participants will take (0), (1) or (2) for each outcome

    Measured: 6 monthes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start4 Oct 2023 (estimated)
  3. Primary completion11 Oct 2023 (estimated)
  4. Study completion11 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05872074
Sponsor's protocol ID
CardioAinShams
Acronym
DCB
Status last verified
May 2023
First submitted
14 Apr 2023
Last updated
24 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27161619

  • 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.

    PubMed 29227279

  • 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.

    PubMed 20194880

  • 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.

    PubMed 21955612

  • 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.

    PubMed 32473887

  • 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.

    PubMed 32742886

  • 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.

    PubMed 12127606

  • 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.

    PubMed 22386286

  • 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.

    PubMed 21173348

  • 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.

    PubMed 19027969

  • 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.

    PubMed 30667361

  • 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.

    PubMed 26824602

Questions about this trial

What is this clinical trial studying?

A study testing Coronary angiography plus percutenous coronary intervention in people with Ischemia; Heart and Stents, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed M Hassan, MSc (01002464361 ext. 02, Am.hassan88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (Number of participants complains of one of MACE ) (time frame: 6 monthes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05872074, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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