Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.

NCT04881812 | Unknown DMC

• 1 other identifier: VUmc_2020.0679
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

This is an investigator-initiated, randomized, multi-center, non-inferiority clinical trial. Patients with a Chronic Total Occlusion who are eligible for PCI will be randomized to additional Drug-Coated-Balloon treatment or stenting of adjacent residual disease to the CTO body. The aim of this study is to investigate whether treatment with DCB is non-inferior to complete stenting of the CTO body.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

Drug-coated balloon; Drug-eluting stent; Randomized controlled trial; PCI

Outcome Measures

Primary Outcomes (1)

• In-segment diameter stenosis

  The primary outcome is to investigate percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS).

  1 year

Secondary Outcomes (3)

• Invasive

  1 year

• Clinical (MACE)

  1 year

• Clinical (angina)

  At inclusion and 1-year follow-up

Other Outcomes (1)

• Tertiary outcome

  1 year

Study Arms (2)

Drug-coated balloon

EXPERIMENTAL

Patients will receive stenting of the actual CTO body with additional DCB treatment of the residual disease of the coronary artery.

Device: Drug-Coated Balloons

Drug-eluting stent

ACTIVE COMPARATOR

Patients will receive complete stenting of the CTO body and residual disease of the coronary artery.

Device: Drug-Eluting-Stent

Interventions

Drug-Coated Balloons DEVICE

Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).

Drug-coated balloon

Drug-Eluting-Stent DEVICE

Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).

Drug-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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

You may not qualify if:

• Dissection affecting the flow (TIMI score\<3), significant recoil (\>30%) or coronary perforation after predilation
• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (2)

VUmc

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Amsterdam Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (10)

• 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.

  PMID: 26189193 BACKGROUND

• 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.

  PMID: 27788851 BACKGROUND

• 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.

  PMID: 17321312 BACKGROUND

• 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.

  PMID: 20170876 BACKGROUND

• 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.

  PMID: 20398864 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

• 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.

  PMID: 30170854 BACKGROUND

• 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.

  PMID: 31204115 BACKGROUND

• 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.

  PMID: 23982467 BACKGROUND

• 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.

  PMID: 40204209 DERIVED

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Paul Knaapen, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvemarie Somsen, MD

CONTACT

+312 (0)444 3272; y.somsen@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Interventional Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 11, 2021
• Study Start: June 17, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)