VISION Registry
This study was a nonrandomized evaluation of the MULTI-LINK RX VISION™ Coronary Stent System (CSS) in the treatment of patients with de novo native coronary artery lesions. The primary objective of this registry was to assess the safety and effectiveness of the MULTI-LINK RX VISION CSS. The study was designed as an open-label, nonrandomized registry that enrolled 268 male and female patients who satisfied the entry criteria. Safety and efficacy of the MULTI-LINK RX VISION CSS were evaluated by analyzing all endpoints and adverse events. The primary endpoint was analyzed on an intent-to-treat basis and all secondary endpoints were analyzed on per protocol evaluable patients.
Location
22 US and international clinical sites
Sample Size
268 enrolled patients
Key Trial Dates
Enrollment began: August 2001
Trial completed: June 2002
Trial Design
A prospective, nonrandomized, multicenter, consecutive enrollment registry
Key Inclusion and Exclusion Criteria
Some inclusion and exclusion criteria for this trial are listed below. More specific criteria were used in screening candidates for this registry.
Inclusion
- Patient is ≥ 18 years old
- Patient is an acceptable candidate for coronary artery bypass graft (CABG) surgery and must have angina or a positive functional study with planned single de novo lesion treatment in a native coronary artery
- Target vessel must be a major coronary artery or major branch
Exclusion
- Patient has known hypersensitivity or contraindication to cobalt, chromium, nickel, stainless steel, aspirin, heparin, or ticlopidine (or clopidogrel), or sensitivity to contrast that cannot be adequately premedicated
- Patient has suffered a myocardial infarction within 3 days of procedure, has suffered a stroke or transient ischemic attack within the past 180 days, has extensive peripheral vascular disease or extreme anticoagulation, and/or has experienced a significant gastrointestinal (GI) bleed within the past 180 days
Primary and Secondary Endpoints
Primary Endpoint
- Target vessel failure (TVF) at 180 days
Secondary Endpoints
- Acute success, major adverse cardiac event (MACE) rates, clinically driven target site revascularization (TSR) at 180 days, clinically driven target vessel revascularization (TVR) at 180 days, angiographic in-stent binary restenosis (≥50%) at 180 days
Regulatory Approval Status
Device received FDA approval in 2003.
Key Results
The purpose of this study was to evaluate the safety and efficacy of the MULTI-LINK VISION CSS by comparing the clinical results to the results of the FDA approved MULTI-LINK TETRA™ CSS. The patient population in the VISION Registry was similar to that of the TETRA Registry, both in demographic and angiographic vessel and lesion characteristics; thus the assumption of treatment group comparability was supported.
Acute and early outcomes were similar in the VISION Registry compared with the TETRA Registry. This was demonstrated by the comparable rates of device success, procedure success, SAT, 30-day MACE, and TVF. In the VISION registry, the 180-day TVF rate was 6.7% compared with the 180-day TVF rate of 12.8% (P = 0.0346) in the TETRA Registry.
Study success was based on an analysis of the primary endpoint (TVF at 180 days) and was directly compared with an expected performance criterion (22.4%). The null hypothesis was tested using the Clopper-Pearson exact upper 95% confidence interval on the observed 180-day TVF rate. The upper 95% confidence interval of the observed 180-day TVF rate was 10.4%, which was considerably lower than the expected performance criterion of 22.4%, enabling the rejection of the null hypothesis in favor of the alternative. The results of the VISION Registry supported the hypothesis of the protocol and demonstrated the 180-day safety and efficacy of this stent for the treatment of patients with de novo lesions in native coronary arteries.
View the summary of safety and effectiveness:
http://www.fda.gov/cdrh/pdf2/P020047b.pdf
View the product specifications and instructions for use:
MULTI-LINK VISION® Coronary Stent System
LT2922560
