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DESSOLVE I Clinical Trial

The DESSOLVE I trial conducted in New Zealand, Australia and Belgium was the first clinical assessment of safety and efficacy of the MiStent SES. The study was an open-label, non-randomized, single-arm study that treated 30 patients, all of whom had documented stable or unstable angina pectoris or ischemia, de novo lesions in coronary arteries ranging in diameter from 2.5-3.5mm and were amenable to treatment with a maximum 23mm length stent. Three independent subgroups of 10 patients each were evaluated using angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at three time points: four, six and eight months post index procedure.

The primary endpoint for the study was in-stent late lumen loss, and secondary endpoints included major adverse cardiac events (MACE) and revascularization rates (by IVUS and OCT). Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point.

Four-year data showed a long-term safety profile with 0% target lesion failure (TLF) and 0% stent thrombosis (ST).

Principal Investigators:

William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium
John Ormiston, M.B.Ch.B., Mercy Angiography Unit, Auckland, New Zealand

More information on the DESSOLVE I trial can be found here.

Read the publications related to this study:
Serial Assessment by Optical Coherence Tomography of Early and Late Vascular Responses After Implantation of an Absorbable-Coating Sirolimus-Eluting Stent (from the First-in-Human DESSOLVE I Trial)

First-In-Human Evaluation of a Bioabsorbable Polymer-Coated Sirolimus-Eluting Stent Imaging and Clinical Results of the DESSOLVE I Trial

Evaluation of a crystalline sirolimus-eluting coronary stent with a bioabsorbable polymer designed for rapid dissolution: two-year outcomes from the DESSOLVE I and II trials

Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies