Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

NCT04660240 | Recruiting DMC

• 1 other identifier: INCAR-DG-DI-342-2020
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, controlled, blind, single-center and non-inferiority clinical trial to compare the target lesion failure (TLF) at 12 months in patients with diabetes mellitus who underwent percutaneous coronary intervention with an Orsiro stent vs. Abluminus stent.

Conditions

Diabetes Mellitus; Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Diabetes Mellitus; Albuminus; Orsiro; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Rate of Target Lesion Failure (TLF)

  To compare the rate of target lesion failure (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization)

  12 months

Secondary Outcomes (12)

• Cardiovascular Death

  12 months

• Myocardial Infarction (MI)

  12 months

• Target Lesion Revascularization (TLR)

  12 months

• Target vessel revascularization (TVR)

  12 months

• Target vessel failure (TVF)

  12 months

Study Arms (2)

Abluminus Sirolimus Eluting Stent System (ASES)

ACTIVE COMPARATOR

The Abluminus sirolimus eluting stent manufactured by Envision and distributed by Concept Medical.

Device: Abluminus Sirolimus Eluting Stent System (ASES)

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

EXPERIMENTAL

The Orsiro sirolimus eluting stent manufactured by Biotronik.

Device: Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Interventions

Abluminus Sirolimus Eluting Stent System (ASES) DEVICE

The procedure will be conducted in accordance with the CE mark instructions for use for the ASES. The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Abluminus Sirolimus Eluting Stent System (ASES)

Orsiro Sirolimus Eluting Coronary Stent System (OSES) DEVICE

The procedure will be conducted in accordance with the CE mark instructions for use for the OSES. The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Eligibility Criteria

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

You may qualify if:

• Men and women over 18 years of age.
• Provide informed consent and agree to follow up as stipulated in the protocol.
• Diabetes mellitus. Whether it is DM 1 or 2 previously diagnosed or newly diagnosed by:
• Fasting glucose\> 126 mg / dl (for study terms, fasting will be defined as the absence of caloric intake for\> 8 hours)
• Tolerance curve to glucose (75 grams of glucose orally) with a glycemia at 2 hours\> 200 mg / dl or,
• HbA1C\> 6.5%.
• Coronary artery disease including chronic coronary syndrome, silent ischemia, or non-ST-segment elevation acute coronary ischemic syndrome.
• Presence of 1 or more de novo coronary lesions in native coronary arteries with a site of maximum stenosis\> 50% that may be amenable to stenting; without limitation in the number of lesions or vessels affected.

You may not qualify if:

• Cardiogenic shock.
• Allergy to acetylsalicylic acid, clopidogrel, ticagrelor, prasugrel, heparin, sirolimus or contrast medium, which cannot be adequately premedicated.
• Acute ST-segment elevation myocardial infarction candidate for primary or urgent coronary angioplasty.
• Left main coronary artery disease.
• In-stent restenosis.
• Lesions in venous or arterial grafts.
• Surgery (cardiac or non-cardiac) planned within 6 months of PCI, unless dual antiplatelet therapy can be continued in the periprocedural period.
• Inability to provide informed consent.
• Life expectancy \<1 year

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Guering Eid Lidt, MD

  Instituto Nacional de Cardiología Ignacio Chávez

  STUDY DIRECTOR

• Julio I Farjat Pasos, MD MSc

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

• Walter O Magaña Ornelas, MD

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

• Alejandra D Portillo Romero, MD

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

• José A Ayón Martínez, MD

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra D Portillo Romero, MD

CONTACT

+52 55 5573 2911; aleportilloromero@gmail.com

Guering Eid Lidt, MD

CONTACT

55 5573 2911; guering@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Diabetic patients undergoing percutaneous coronary intervention in de novo lesions are going to be randomized to two groups. One will have percutaneous coronary intervention with Abluminus sirolimus eluting stent implantation, and the other will have percutaneous coronary intervention with Orsiro Sirolimus Eluting stent implantation. The implantation of both stents will be guided by angiography only. In a subgroup of both arms (100 patients per group) the implantation will be also guided by intravascular ultrasound.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

ME (1)