Resolute Integrity US Extended Length Sub-Study(RI US XL)

Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01913600

Acronym

RI-US XL

Enrollment

Registered

2013-08-01

Start date

2013-07-31

Completion date

2018-12-31

Last updated

2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), Coronary Artery Disease, MYOCARDIAL INFARCTION (MI), PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT THROMBOSIS, TARGET LESION FAILURE (TLF)

Brief 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.

Detailed description

The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System. Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.

Interventions

DEVICEResolute Integrity Stent

Drug eluting stent (DES)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 \<100,000 cells/mm³ or \>700,000 cells/mm³; White blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>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

Design outcomes

Primary

Measure	Time frame	Description
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)	12 months	The combined clinical outcome of (all cause) mortality, MI or any revascularization

Secondary

Measure	Time frame	Description
Composite Endpoint: Major Adverse Cardiac Events (MACE)	30 days, 6 months, 12 months	Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
Composite Endpoint: Target Lesion Failure (TLF)	30 days, 6 months, 12 months	Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods
Composite Endpoint: Target Vessel Failure (TVF),	30 days, 6 months, 12 months	The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Composite Endpoint: Cardiac Death and Target Vessel MI	30 days, 6 months, 12 months	Combined rate of cardiac death and target vessel MI post-procedure
Composite Endpoint: Target Vessel MI	30 days, 6 months, 12 months	Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.
Clinical Endpoint: Death	30 days, 6 months, 12 months	All deaths including cardiac death, vasular death and non-cardiovascular death
Clinical Endpoint: Myocardial Infarction (MI)	30 days, 6 months, 12 months	All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
Clinical Endpoint: Target Lesion Revascularization (TLR)	30 days, 6 months, 12 months	Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.
Clinical Endpoint: Target Vessel Revascularization (TVR)	30 days, 6 months, 12 months	Repeat PCI or CABG of the target vessel.
Clinical Endpoint: Stent Thrombosis	Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)	All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions
Clinical Endpoint: Stroke	30 days, 6 months, 12 months	Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
Clinical Endpoint: Bleeding Complications in General	30 days, 6 months, 12 months	Bleeding complications in general including the GUSTO classification of Severe, Moderate & Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.
Dual Antiplatelet Therapy (DAPT) Compliance	30 days, 6 months, 12 months	Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.

Countries

United States

Participant flow

Recruitment details

56 XL subjects were enrolled from 9 study sites in the United States. The first subject was enrolled on July 26, 2013 and the last subject was enrolled on October 27, 2015.

Participants by arm

Arm	Count
Resolute Integrity US Extended Length Sub-Study (RI-US XL) Resolute Integrity Stent Resolute Integrity Stent: Drug eluting stent (DES) Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.	56
Total	56

Arm

Count

Resolute Integrity US Extended Length Sub-Study (RI-US XL)

Resolute Integrity Stent Resolute Integrity Stent: Drug eluting stent (DES) Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.

Total

Baseline characteristics

Characteristic	Resolute Integrity US Extended Length Sub-Study (RI-US XL)
Age, Continuous	60.5 Years STANDARD_DEVIATION 10.7
Region of Enrollment United States	56 participants
Sex: Female, Male Female	13 Participants
Sex: Female, Male Male	43 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 56
other Total, other adverse events	45 / 56
serious Total, serious adverse events	45 / 56

Outcome results

Primary