Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.
NCT ID: NCT04881812
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2021-06-17
2025-03-31
Brief Summary
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Detailed Description
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Objective: To investigate the value of DCB treatment in the residual disease of the coronary artery after successful recanalization and stenting of the actual CTO body as compared with complete stenting in a randomized fashion.
Study design: This is an investigator-initiated, randomized, single-blind (patients will be masked), multicenter, non-inferiority clinical trial.
Study population: 154 patients with a CTO eligible for PCI based on a formal local heart team decision will be screened for potential inclusion in the study.
Intervention: Patients with a CTO who are eligible for PCI will be randomized in a 1:1 ratio to additional DCB treatment or stenting of residual disease.
Main study parameters/endpoints: The primary endpoint is percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS). Secondary invasive imaging objectives include minimal lumen diameter, late luminal loss, in-segment binary restenosis, and target vessel re-occlusion at 1-year follow-up. Secondary clinical objectives are evaluation of the occurrence of major adverse cardiac events (MACE) at 1-year follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group-relatedness: Participation in this study entails additional measurements, namely follow-up coronary angiography at 12 months, CCTA-scan at 12 months (if participating in substudy), and telephonic follow-up at 30 days and 12 months.
All patients included in the trial will have a clinical indication for percutaneous revascularization. Since there are no randomized controlled trials which advocate the use of either DES or DCB over one another in this setting, the risk of the PCI procedure will not be related to study participation. All patients will undergo coronary angiography after 1-year follow-up and will thus be exposed to the risks of invasive coronary angiography. Coronary angiography is characterized by a low complication rate (\<0.5%). Repeat angiography also carries a low amount of radiation exposure. Patients participating in the CCTA substudy will be exposed to additional radiation. The ionized contrast agents used in both coronary angiography and CCTA substudy can be nephrotoxic and can elicit allergic reactions.
A DCB facilitated minimal stenting strategy for treatment of chronic total occlusions may significantly reduce stent length, number of used stents, as well as compression of the distal lumen with undersized stents. While DCB is expected to be non-inferior to DES regarding the in-segment diameter stenosis (primary endpoint), possible benefits may be observed in the secondary endpoints. Consequently, this trial could influence current guidelines on the application of DCBs in CTO procedures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Drug-coated balloon
Patients will receive stenting of the actual CTO body with additional DCB treatment of the residual disease of the coronary artery.
Drug-Coated Balloons
Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).
Drug-eluting stent
Patients will receive complete stenting of the CTO body and residual disease of the coronary artery.
Drug-Eluting-Stent
Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).
Interventions
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Drug-Coated Balloons
Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).
Drug-Eluting-Stent
Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for revascularization of the CTO as determined by the local heart team (based on symptoms, documented ischemia, and viability)
* Successful recanalization of the CTO with residual disease adjacent to the initial lesion
Exclusion Criteria
* Reference diameter of the vessel is \<2.5 mm or \>4.0 mm
* Bifurcation lesion requiring the stenting of the side branch
* Left main lesion
* Acute coronary syndrome
* Cardiogenic shock
* Severe kidney disease defined as an eGFR \< 30 ml/min
* Pregnancy
* Life expectancy \< 12 months
* Inability to give written consent
18 Years
ALL
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Paul Knaapen
Principal Investigator, Professor of Interventional Cardiology
Principal Investigators
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Paul Knaapen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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VUmc
Amsterdam, North Holland, Netherlands
Amsterdam Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Christopoulos G, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman RM, Lombardi WL, Menon RV, Grantham JA, Kandzari DE, Lembo N, Moses JW, Kirtane AJ, Parikh M, Green P, Finn M, Garcia S, Doing A, Patel M, Bahadorani J, Tarar MN, Christakopoulos GE, Thompson CA, Banerjee S, Brilakis ES. Application and outcomes of a hybrid approach to chronic total occlusion percutaneous coronary intervention in a contemporary multicenter US registry. Int J Cardiol. 2015 Nov 1;198:222-8. doi: 10.1016/j.ijcard.2015.06.093. Epub 2015 Jun 27.
Maeremans J, Walsh S, Knaapen P, Spratt JC, Avran A, Hanratty CG, Faurie B, Agostoni P, Bressollette E, Kayaert P, Bagnall AJ, Egred M, Smith D, Chase A, McEntegart MB, Smith WH, Harcombe A, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. The Hybrid Algorithm for Treating Chronic Total Occlusions in Europe: The RECHARGE Registry. J Am Coll Cardiol. 2016 Nov 1;68(18):1958-1970. doi: 10.1016/j.jacc.2016.08.034.
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.
Fearon WF. Impact of drug-eluting stent length on outcomes less is more...more or less. JACC Cardiovasc Interv. 2010 Feb;3(2):189-90. doi: 10.1016/j.jcin.2009.12.006. No abstract available.
Suh J, Park DW, Lee JY, Jung IH, Lee SW, Kim YH, Lee CW, Cheong SS, Kim JJ, Park SW, Park SJ. The relationship and threshold of stent length with regard to risk of stent thrombosis after drug-eluting stent implantation. JACC Cardiovasc Interv. 2010 Apr;3(4):383-9. doi: 10.1016/j.jcin.2009.10.033.
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.
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.
Kleber FX, Rittger H, Bonaventura K, Zeymer U, Wohrle J, Jeger R, Levenson B, Mobius-Winkler S, Bruch L, Fischer D, Hengstenberg C, Porner T, Mathey D, Scheller B. Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol. 2013 Nov;102(11):785-97. doi: 10.1007/s00392-013-0609-7. Epub 2013 Aug 28.
Somsen YBO, de Winter RW, Wu J, Hoek R, Sprengers RW, Verouden NJ, Claessen BEPM, Kleijn SA, Twisk JWR, Henriques JP, Spratt JC, Rissanen TT, McEntegart MB, Maehara A, Nap A, Knaapen P. Design and rationale of the drug-coated balloon coronary angioplasty versus stenting for treatment of disease adjacent to a chronic total occlusion (Co-CTO) trial. Am Heart J. 2025 Oct;288:65-76. doi: 10.1016/j.ahj.2025.03.023. Epub 2025 Apr 7.
Other Identifiers
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VUmc_2020.0679
Identifier Type: -
Identifier Source: org_study_id
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