Chronic Total Occlusion of Coronary ArteryCo-CTONCT04881812
Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.
A study testing Drug-Coated Balloons and Drug-Eluting-Stent in people with Chronic Total Occlusion of Coronary Artery, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- Drug-Coated Balloons and Drug-Eluting-Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesNetherlands
- Study dates
- 17 Jun 2021to 31 Mar 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Severe kidney disease defined as an eGFR < 30 ml/min
- Pregnancy
- Life expectancy < 12 months
- Inability to give written consent
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
VUmc
Amsterdam, North Holland, 1081HV
Yvemarie Somsen, MD, +312 (0)444 3272, y.somsen@amsterdamumc.nl
Paul Knaapen, MD, PhD
- Recruiting
Amsterdam Medical Center
Amsterdam, North Holland, 1105AZ
Yvemarie Somsen, MD, +312 (0)444 3272, y.somsen@amsterdamumc.nl
Paul Knaapen, MD PhD
About this study
Official title: A Randomized, Multi-center, Non-inferiority Clinical Trial on the Treatment of Residual Disease With Drug-Coated Balloon After Successful Recanalization and Limiting Stenting to the CTO Body Compared to Complete Stenting of the CTO Body and Adjacent Residual Disease.
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.
Read the detailed description
Rationale: Chronic total coronary occlusions (CTOs) are documented in approximately 16-18% of diagnostic coronary angiograms. New developments such as retrograde approach and dissection re-entry techniques have resulted in more widespread application of percutaneous coronary intervention (PCI) of CTOs, and this technique now serves as a viable alternative to optimal medical therapy alone or coronary artery bypass surgery. In general, PCI CTO is accompanied by extensive stenting of the coronary artery beyond the original occlusive segment itself. Unfortunately, stent length and diameter are directly related to poorer outcome, which is related to an increased rate of in-stent restenosis and thrombosis. An alternative to stenting is the application of drug-coated balloons (DCB). This strategy may prove beneficial, as it could significantly reduce stent length, among other things. However, data on the use of DCBs in the context of PCI CTO are currently lacking.
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.
- Being tested
- Drug-Coated Balloons, Drug-Eluting-Stent
- Keywords
- Drug-coated balloon, Drug-eluting stent, Randomized controlled trial, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated BalloonsDevice
Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).
Drug-Eluting-StentDevice
Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Drug-Eluting-Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment diameter stenosis
The primary outcome is to investigate percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS).
Measured: 1 year
Secondary outcomes (3)
Invasive
- Minimal lumen diameter (millimeters)
- Late luminal loss (millimeters)
- In-segment binary restenosis (>50%)
- Target vessel re-occlusion (yes/no)
Measured: 1 year
Clinical (MACE)
Major adverse cardiac events (MACE). MACE is composite endpoint of cardiac death, non-fatal myocardial infarction and ischemia driven target lesion revascularization (ID-TLR)
Measured: 1 year
Clinical (angina)
Occurrence of angina pectoris according to the Canadian Cardiovascular Society Grading Scale (grade 1-4):
- Angina only during strenuous or prolonged physical activity;
- Slight limitation, with angina only during vigorous physical activity;
- Symptoms with everyday living activities, i.e. marked limitation;
- Inability to perform any activity without angina or angina at rest, i.e. severe limitation.
Measured: At inclusion and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start17 Jun 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Knaapen, Amsterdam UMC, location VUmc
- Investigators
- Paul Knaapen, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881812
- Sponsor's protocol ID
- VUmc_2020.0679
- Acronym
- Co-CTO
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26189193Maeremans 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.
PubMed 27788851Daemen 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.
PubMed 17321312Fearon 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.
PubMed 20170876Suh 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.
PubMed 20398864Neumann 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 30667361Jeger 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.
PubMed 30170854Rissanen 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.
PubMed 31204115Kleber 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.
PubMed 23982467Somsen 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.
PubMed 40204209
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Non-inferiority Clinical Trial on the Treatment of Residual Disease With Drug-Coated Balloon After Successful Recanalization and Limiting Stenting to the CTO Body Compared to Complete Stenting of the CTO Body and Adjacent Residual Disease.
- ClinicalTrials.gov ID
- NCT04881812
- Acronym / sponsor ID
- Co-CTO / VUmc_2020.0679
- Keywords
- Drug-coated balloon, Drug-eluting stent, Randomized controlled trial, PCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Chronic total coronary occlusions (CTOs) are documented in approximately 16-18% of diagnostic coronary angiograms. New developments such as retrograde approach and dissection re-entry techniques have resulted in more widespread application of percutaneous coronary intervention (PCI) of CTOs, and this technique now serves as a viable alternative to optimal medical therapy alone or coronary artery bypass surgery. In general, PCI CTO is accompanied by extensive stenting of the coronary artery beyond the original occlusive segment itself. Unfortunately, stent length and diameter are directly related to poorer outcome, which is related to an increased rate of in-stent restenosis and thrombosis. An alternative to stenting is the application of drug-coated balloons (DCB). This strategy may prove beneficial, as it could significantly reduce stent length, among other things. However, data on the use of DCBs in the context of PCI CTO are currently lacking.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | Experimental | Device: Drug-Coated BalloonsPatients will receive stenting of the actual CTO body with additional DCB treatment of the residual disease of the coronary artery. |
| Drug-eluting stent | Active comparator | Device: Drug-Eluting-StentPatients will receive complete stenting of the CTO body and residual disease of the coronary artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-Coated BalloonsPercutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy). | Device | Drug-coated balloon |
| Drug-Eluting-StentPercutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy). | Device | Drug-eluting stent |
Primary outcome
In-segment diameter stenosis
Time frame: 1 year
The primary outcome is to investigate percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS).
3 secondary outcomes
Invasive
Time frame: 1 year
Clinical (MACE)
Time frame: 1 year
Clinical (angina)
Time frame: At inclusion and 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 26189193Christopoulos 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.
- Background: PubMed 27788851Maeremans 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.
- Background: PubMed 17321312Daemen 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.
- Background: PubMed 20170876Fearon 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.
- Background: PubMed 20398864Suh 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.
- Background: PubMed 30667361Neumann 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.
- Background: PubMed 30170854Jeger 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.
- Background: PubMed 31204115Rissanen 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.
- Background: PubMed 23982467Kleber 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.
- Derived from this study: PubMed 40204209Somsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Knaapen, MD PhD principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Coated Balloons and Drug-Eluting-Stent in people with Chronic Total Occlusion of Coronary Artery, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
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 10 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Yvemarie Somsen, MD (+312 (0)444 3272, y.somsen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment diameter stenosis (time frame: 1 year). 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 NCT04881812, which also lists 10 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 22 Sep 2023.