N/A
Completed N=159
Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System
Source: ClinicalTrials.gov NCT01788150 ↗Enrolled (actual)
159
Serious AEs
18.2%
Results posted
May 2021
Primary outcomePrimary: Angiographic In-Stent Late Lumen Loss (LL) — 0.09; 0.13 mm
Summary
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.
The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Angiographic In-Stent Late Lumen Loss (LL) |
0.09; 0.13 | — |
| SECONDARY Number of Participants Clinically-driven Target Lesion Revascularization (TLR) |
2; 1 | — |
| SECONDARY Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization |
4; 4 | — |
| SECONDARY Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels |
18; 9 | — |
| SECONDARY Number of Participants Stent Thrombosis |
0; 0 | — |
| SECONDARY Number of Participants Acute Success Rates |
2; 0; 96; 45; 104; 51 | — |
| SECONDARY Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate |
2; 0; 5; 0 | — |
| SECONDARY In-stent and In-segment Minimum Lumen Diameter |
2.28; 2.52; 2.07; 2.26 | — |
| SECONDARY In-segment Late Lumen Loss |
0.04; -0.02 | — |
| SECONDARY Neointimal Hyperplasia as Measured by OCT |
11.3 | — |
| SECONDARY Strut Coverage |
94.2 | — |
| SECONDARY Number of Participants Target Vessel Failure |
7; 5 | — |
Eligibility Criteria
Inclusion Criteria
General Inclusion Criteria
- Patient is ≥18 years old;
- Patient is eligible for percutaneous coronary intervention (PCI);
- Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
- Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
- Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
- Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and
- Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
Angiographic Inclusion Criteria
- Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;
- If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
- Residual diameter stenosis 700, 000 cells/mm3 or a WBC 170μmol/L);
- History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
- Patients requiring ongoing anticoagulation with warfarin or dabigatran.
Angiographic Exclusion Criteria
- Total occlusion (TIMI 0 or 1);
- Target vessel has angiographic evidence of thrombus
- Target vessel is excessively tortuous or has heavy calcification;
- Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
- Target lesion is located in or supplied by an arterial or venous bypass graft;
- Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
- Target lesion involves a side branch > 2.0 mm in diameter; and
- Unprotected Left Main coronary disease (stenosis > 50%).
Data sourced from ClinicalTrials.gov (NCT01788150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.