Selution de-novo

A Prospective Randomized, Multi-center, International, Open label, Clinical trialcomparing the SELUTION DEB strategy versus DES strategy

09.12.2022 bis 31.12.2028

Randomized, multi-center, international, single-blind, clinical trial.
Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLRTM DEB or DES.
Patients randomized to the SELUTION SLRTM DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis).
Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate.
Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm).
The study will test:
1) for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months.
2) for long-term superiority at 5 years of the DEB strategy with TVF as an endpoint
All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.