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.

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.