AzTrials
AzTrials

Coronary Artery DiseaseNCT04789161

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

An observational study of Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
double kissing crush stenting and double kissing culotte stenting
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Mar 2021to 4 May 2024
How long will I take part?
12 Months
Phase
Observational
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with stable or unstable angina pectoris or patients with non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention and performing double stent techniques (DK-crush or DK-culotte) are included in this study.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients with active bleeding
  • Pregnant women
  • Patients with life-expectancy < 1 year

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Mehmet Akif Ersoy Training and Research Hospital

    Istanbul, 34303

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
double kissing crush stenting, double kissing culotte stenting
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.

  • double kissing crush stentingProcedure or surgery

    Patients with true bifurcation lesion treating with double kissing crsuh stenting technique

  • double kissing culotte stentingProcedure or surgery

    Patients with true bifurcation lesion treating with double kissing culotte stenting technique

Study groups in NCT04789161
Study groupRoleWhat they receive
double kissing crush stentingpatients with true bifurcation lesion undergoing double kissing crush stenting
Receives: Procedure: double kissing crush stenting
double kissing culotte stentingpatients with true bifurcation lesion undergoing double kissing culotte stenting
Receives: Procedure: double kissing culotte stenting

What is being measured

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

  1. MACE (major adverse cardiovascular events)

    target vessel revascularization, myocardial infarction and cardiac death

    Measured: 12 months

Secondary outcomes (2)

  1. 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

    Measured: 12, 24, 36 months

  2. target lesion failure

    myocardial infarction, cardiac death

    Measured: 24, 36 months

Timeline

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

  1. First posted9 Mar 2021
  2. Study start4 Mar 2021
  3. Primary completion4 Apr 2024
  4. Study completion4 May 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789161
Sponsor's protocol ID
IMAEETH-2
Status last verified
Aug 2024
First submitted
5 Mar 2021
Last updated
16 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 17060387

  • 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.

    PubMed 19103990

  • 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

  • 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.

    PubMed 29096915

  • 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.

    PubMed 32338608

  • Kahraman S, Cizgici AY, Guner A, Tasbulak O, Panc C, Dogan AC, Ulutas AE, Gurbak I, Bulut U, Avci Y, Demir AR, Yalcin AA, Kalkan AK, Erturk M. Clinical Outcomes of Double-Kissing Crush or Double-Kissing Culotte in Nonleft Main Bifurcation Lesions: The ROUTE Trial. Circ Cardiovasc Interv. 2024 Nov;17(11):e014616. doi: 10.1161/CIRCINTERVENTIONS.124.014616. Epub 2024 Oct 24.

    PubMed 39445416

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).

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 2 inclusion and 9 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: finished, as of the sponsor's last update on 16 Aug 2024. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (major adverse cardiovascular events) (time frame: 12 months). 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 NCT04789161, which also lists 6 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 16 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in