Registry of RESOLUTE-ONYX™ Zotarolimus-eluting Stent Utilization in Percutaneous Small Vessel Coronary Interventionism.

NCT04785846 | Completed DMC FDA Device

• 1 other identifier: Disco 9
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 15

Brief Summary

DESIGN: Prospective, single-arm, multicenter, observational, prospective registry of the use of the RESOLUTE-ONYX™ zotarolimus-eluting stent in percutaneous coronary intervention in small vessels. Clinical follow-up at 1 month, 6 months and 1 year. OBJECTIVE: To evaluate the safety and efficacy of using RESOLUTE-ONYX zotarolimus-eluting stent in PCI in small vessels (diameter ≤2.5 mm). DISEASE UNDER STUDY: Adult patients with coronary artery disease (stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome) undergoing percutaneous coronary intervention on vessels with a diameter less than or equal to 2.5 mm. TOTAL NUMBER OF PATIENTS: Approximately 320 patients are expected to be included in the study.

Conditions

Coronary Disease; Angina, Stable; Ischemia; Acute Coronary Syndrome; Percutaneous Coronary Intervention

Keywords

Small vessels; Coronary Disease; Angina, Stable; Ischemia; Acute Coronary Syndrome; Percutaneous Coronary Intervention; Stent

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiac Events (MACE)

  Incidence of Major Adverse Cardiac Events (MACE) defined as a composite of: death of cardiac origin, target vessel-related myocardial infarction and/or new target lesion revascularization (percutaneous or surgical).

  1 year

Secondary Outcomes (6)

• Success of the procedure

  In the procedure

• Periprocedural myocardial infarction

  In the procedure

• Each of the separate components of the combined event: Death of cardiac origin, target vessel-related myocardial infarction, new target lesion revascularization (percutaneous or surgical)

  1 month, 6 months, 1 year.

• Acute/sub-acute thrombosis

  1 month, 6 months, 1 year

• Bleeding unrelated to surgical revascularization

  1 month, 6 months, 1 year

Study Arms (1)

Single Group

Adult patients with coronary artery disease undergoing percutaneous coronary intervention on vessels with a diameter less than or equal to 2.5 mm.

Device: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention DEVICE

Percutaneous Coronary Intervention

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with coronary artery disease (stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome) undergoing percutaneous coronary intervention on vessels with a diameter less than or equal to 2.5 mm.

You may qualify if:

• Signature of the Informed Consent in writing.
• Patients over 18 years of age.
• Males or post-menopausal women or women under contraceptive treatment. Women of childbearing age must have a negative pregnancy test.
• Diagnosis of stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q infarction).
• De novo coronary artery disease, single-vessel or multivessel, with stenosis \>70% according to visual estimation, susceptible to treatment with intracoronary stenting.
• Coronary stenosis involving a vessel with diameter ≥2 mm and ≤2.5 mm.
• Implantation of the RESOLUTE-ONYX™ zotarolimus-eluting stent used according to the indications for use in routine clinical practice at the center.

You may not qualify if:

• Acute myocardial infarction with ST-segment elevation during the hospitalization in which the patient is included.
• Significant stenosis of the left coronary artery trunk.
• In-stent restenosis.
• Chronic total occlusion.
• Stenosis in aorto-coronary grafts of saphenous vein or mammary or radial artery.
• Hemorrhagic diathesis or high risk of bleeding.
• Treatment with oral anticoagulants.
• Allergy to aspirin, clopidogrel, prasugrel or ticagrelor.
• Known allergy to zotarolimus, nickel, chromium, or cobalt.
• Women who are pregnant, breastfeeding or expect to become pregnant within the next year.
• Participation in another clinical study.
• Limited life expectancy (\< 1 year).
• Planned major elective surgery
• Unable to complete follow-up.

Sponsors & Collaborators

• Fundación Investigación Sanitaria en León: lead

Study Sites (15)

University Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

University Hospital of Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

University Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

University Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

University Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

University Hospital of Cabueñes

Gijón, Principality of Asturias, 33394, Spain

Location

University Hospital of Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

University Hospital of Torrecárdenas

Almería, 04009, Spain

Location

University Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

University Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

León University Health Care Complex

León, 24081, Spain

Location

University Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

University Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

Location

University Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

University Hospital Txagorritxu

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Conditions

Coronary Disease; Angina, Stable; Ischemia; Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Carlos Cuellas Ramón, MD

  Fundación de Investigación Sanitaria de León

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: October 18, 2017
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)