Direct III
Research type
Research Study
Full title
Direct Implantation of Sirolimus-Eluting Stents with Bioresorbable Drug Carrier Technology Utilizing the Svelte Drug-Eluting Coronary Stent: The DIRECT III Post Market Study
IRAS ID
201502
Contact name
Mohaned Egred
Contact email
Sponsor organisation
Svelte Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an all-comers, real-world population. Coronary artery stenting has evolved substantially since the first use of stents as an adjunct to balloon angioplasty in the early 1990s. The performance of coronary stents has improved considerably, with stenting now the primary mode of revascularization in percutaneous coronary interventions (PCI). The aim of the study is designed to evaluate whether the SLENDER stent shortens the procedure time in patients having this type of procedure. The SLENDER stent is put in to the diseased artery. Whilst opening the narrow part of the artery and keeping it open, it will allow more blood to flow through.
Following the procedure and hospital discharge all participants will be asked to allow a telephone follow-up at 30 day, 6 month and 12 month post-procedure for various assessments and reviews.We are looking to review the efficacy, safety data as well as target lesion outcome at 12 months. Additionally, procedure time and cost saving and patient experience will be captured.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0071
Date of REC Opinion
20 Apr 2017
REC opinion
Further Information Favourable Opinion