N/A
N=56
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01913600 ↗Enrolled (actual)
56
Serious AEs
80.4%
Results posted
Nov 2017
Primary outcome: Primary: Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resolute Integrity Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) |
4 | — |
| SECONDARY Composite Endpoint: Major Adverse Cardiac Events (MACE) |
2; 2; 5 | — |
| SECONDARY Composite Endpoint: Target Lesion Failure (TLF) |
2; 2; 4 | — |
| SECONDARY Composite Endpoint: Target Vessel Failure (TVF), |
2; 2; 4 | — |
| SECONDARY Composite Endpoint: Cardiac Death and Target Vessel MI |
2; 2; 4 | — |
| SECONDARY Composite Endpoint: Target Vessel MI |
2; 2; 3 | — |
| SECONDARY Clinical Endpoint: Death |
0; 0; 1 | — |
| SECONDARY Clinical Endpoint: Myocardial Infarction (MI) |
2; 2; 4 | — |
| SECONDARY Clinical Endpoint: Target Lesion Revascularization (TLR) |
0; 0; 1 | — |
| SECONDARY Clinical Endpoint: Target Vessel Revascularization (TVR) |
0; 0; 1 | — |
| SECONDARY Clinical Endpoint: Stent Thrombosis |
1; 0 | — |
| SECONDARY Clinical Endpoint: Stroke |
0; 0; 0 | — |
| SECONDARY Clinical Endpoint: Bleeding Complications in General |
3; 6; 9 | — |
| SECONDARY Dual Antiplatelet Therapy (DAPT) Compliance |
47; 47; 40 | — |
Summary
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.
Eligibility Criteria
General and Angiographic Inclusion Criteria highlights:
- Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- Informed consent
- Patient agrees to comply with specified follow-up evaluations
- Single target lesion or two target lesions located in separate coronary arteries
- De novo lesion(s) in native coronary artery(ies)
- Target lesion(s) ≤ 35 mm in length
- Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm
General and Angiographic Exclusion Criteria highlights:
- Within 7 days of index procedure platelet count 700,000 cells/mm³; White blood cell (WBC) count 2.5 mg/dl
- Acute Myocardial Infarction (MI) within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (CK-MB) > lab upper limit of normal)
- Previous PCI of target vessel(s) within 9 months prior to the procedure
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- History of stroke or Transient Ischemic Attack (TIA) within prior 6 months
- Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- Inability to comply with required trial antiplatelet regimen
- Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
- Unprotected left main coronary artery disease
Data sourced from ClinicalTrials.gov (NCT01913600). 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.