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Clinical Trial Summary

The DESyne BDS Plus Randomized Clinical Study is a prospective, multi-center, single blind, randomized clinical study. Randomization (1:1; DESyne BDS Plus : DESyne X2) of up to 100 patients (50 in each arm) requiring treatment of up to two de novo coronary artery lesions ≤ 34 mm in length in vessels ≥ 2.25 mm and ≤ 3.5 mm in diameter will be conducted. Clinical endpoints will be assessed at each follow-up point: 3 days or hospital discharge (whichever comes first), 1, 6, and 12 months.


Clinical Trial Description

To evaluate the safety and performance of the DESyne BDS Plus DECSS (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions. The DESyne BDS Plus Randomized Clinical Study is a prospective, multi-center, single blind, randomized clinical study. Randomization (1:1; DESyne BDS Plus : DESyne X2) of up to 100 patients (50 in each arm) requiring treatment of up to two de novo coronary artery lesions ≤ 34 mm in length in vessels ≥ 2.25 mm and ≤ 3.5 mm in diameter will be conducted. Up to two target lesions, located in separate epicardial vessels, which meet the inclusion/exclusion criteria, may be treated with the assigned study device. Alternatively, one target lesion may be treated with the assigned study device after successful, uncomplicated treatment with any commercially-available DES of a non-target lesion, located in a separate epicardial vessel. In an imaging subset of approximately 60 subjects (30 per arm), Angiography and OCT will be performed at index procedure, and again at 6 month follow-up. The PK sub-study will enroll up to 10 non-randomized subjects treated only with the DESyne BDS Plus device, with a maximum of 3 DESyne BDS stents implanted. The PK sub-study is being conducted to assess the blood pharmacokinetics of the three drugs (Sirolimus, Rivaroxaban, Argatroban) eluted from the DESyne BDS Plus after implantation. PK measurements will be conducted by obtaining plasma blood samples at pre-treatment, and post-treatment at 10 minutes, 30 minutes, 1, 2, 4, 6, 12, 24, 72 hours, and 7 days. In addition, all PK subjects will undergo clinical assessments/follow-up at 3 days or hospital discharge (whichever comes first), 1, 6 and 12 months. The PK sub-study subjects are not considered part of the primary analysis population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05033964
Study type Interventional
Source Elixir Medical Corporation
Contact Candace Elek, MS
Phone 408-636-2007
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date September 2021
Completion date July 2023

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