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Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus (INC-DM)

Primary Purpose

Diabetes Mellitus, Coronary Artery Disease, Acute Coronary Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Abluminus Sirolimus Eluting Stent System (ASES)

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Albuminus, Orsiro, Percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Instituto Nacional de Cardiología Ignacio ChávezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Abluminus Sirolimus Eluting Stent System (ASES)

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Arm Description

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

The Orsiro sirolimus eluting stent manufactured by Biotronik.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Cardiovascular Death

Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: Death caused by acute MI Death caused by sudden cardiac, including unwitnessed, death Death resulting from heart failure Death caused by stroke Death caused by cardiovascular procedures Death resulting from cardiovascular hemorrhage Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI. Percutaneous coronary intervention (PCI) related MI is termed type 4a MI. Coronary artery bypass grafting (CABG) related MI is termed type 5 MI. Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.

Myocardial Infarction (MI)

Compare the myocardial infarction related to the treated vessel between both groups. (according to the 4th international definition of myocardial infarction) detection of an increase or decrease in cardiac troponin values with at least 1 of the values above the upper reference limit of the 99th percentile and at least 1 of the following conditions : Symptoms of acute myocardial ischemia. New ischemic changes in the electrocardiogram. Appearance of pathological Q waves. Imaging evidence of loss of viable myocardium or new regional abnormalities in myocardial wall mobility following a pattern compatible with ischemic etiology. Identification of a coronary thrombus by angiography with intracoronary imaging or by autopsy Any MI that cannot be clearly attributed to a vessel other than the revascularized one will be considered as MI related to the treated vessel.

Target Lesion Revascularization (TLR)

Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.

Target vessel revascularization (TVR)

TVR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Target vessel failure (TVF)

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

Death caused by other cardiovascular causes.

Compare death from any cause between the two groups. The following categories will be collected: Malignancy. Pulmonary causes. Infection. Gastrointestinal causes. Accident / trauma. Caused by failure of another non-cardiovascular organ. Other non-cardiovascular causes. Death that cannot be attributed to any of the aforementioned categories due to lack of information will be considered cardiovascular in terms of study outcomes.

Rate of in-stent restenosis (ISR)

Compare the rate of stent edge restenosis between both groups. Stenosis> 50% of the diameter and one or more of the following: symptoms suggestive of ischemia, electrocardiographic changes suggestive of ischemia, significant pressure gradient across the lesion; or a> 70% reduction in luminal area, even in the absence of data suggestive of ischemia. The categories will be collected according to the Waksman In-Stent Restenosis Classification: Type I: mechanical IA Underexpansion IIA Stent fracture Type II: Biologic IIA Intimal hyperplasia IIB Neoatherosclerosis, noncalcified IIC Neoatherosclerosis, calcified Type III: Mixed pattern: Combined mechanical and biologic etiology Type IV: Chronic total occlusion Type V: >2 layers of stent

Rate of stent thrombosis (ST)

Compare the rate of stent thrombosis between both groups, According to the definition of the Academic Research Consortium (ARC) -2: Definitive thrombosis. Probable thrombosis. Silent occlusion. Temporality: acute (0-24 hours), subacute (> 24 hours to 30 days), late (> 30 days to 1 year) and very late (> 1 year).

Major bleeding

Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater.

Rate of Cerebrovascular Event

Compare the rate of cerebrovascular event between both groups according to Neuro-ARC stroke/ Transient ischemic attack (TIA) criteria.

Contrast Nephropathy

Creatinine increase >0.5 mg / dl or >25% over baseline at 48 hours after the procedure.

Technical Success

Technical success is defined as the ability to cross the occluded segment with both a wire and a balloon, and successfully open the artery; the restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a <30% residual stenosis.

Full Information

NCT ID

NCT04660240

First Posted

December 3, 2020

Last Updated

October 14, 2022

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

1. Study Identification

Unique Protocol Identification Number

NCT04660240

Brief Title

Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

Acronym

INC-DM

Official Title

Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Worldwide, and especially in Mexico, there is a high incidence of diabetes mellitus (DM), which in turn, confers a higher cardiovascular risk in this population. Diabetic patients undergoing PCI have worse outcomes than non-diabetics regardless of the degree of complexity of their coronary anatomy. Although the 30-day in-hospital outcomes have been similar between diabetic and non-diabetic patients, DM has been invariably associated with greater stent failure with target vessel revascularization (TVR), major adverse cardiovascular event (MACE), and mortality in the long-term follow-up, even with the use of drug-eluting stents. In relation to the above, two of the sirolimus-eluting stents (SES): the Abluminus and the Orsiro, have been considered as promising options in patients with DM. The Abluminus stent has been designed for diabetic patients in order to reduce cardiovascular events. Said stent consists of a cobalt-chromium platform covered with a layer of biodegradable polymer and mounted on a balloon, both sirolimus-releasing. The Rate of target lesion failure (TLF) reported to date in diabetic patients is 3.8%. On the other hand, the Orsiro stent, a cobalt-chromium platform with ultrathin struts, has had favorable results in different clinical settings and patients with different characteristics]; specifically in a subgroup analysis in DM, a TLF rate of 3.5% was reported

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Coronary Artery Disease, Acute Coronary Syndrome

Keywords

Diabetes Mellitus, Albuminus, Orsiro, Percutaneous coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Participant

Allocation

Randomized

Enrollment

860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Abluminus Sirolimus Eluting Stent System (ASES)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Arm Type

Experimental

Arm Description

The Orsiro sirolimus eluting stent manufactured by Biotronik.

Intervention Type

Device

Intervention Name(s)

Abluminus Sirolimus Eluting Stent System (ASES)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Target Lesion Failure (TLF)

Description

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)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Cardiovascular Death

Description

Time Frame

12 months

Title

Myocardial Infarction (MI)

Description

Time Frame

12 months

Title

Target Lesion Revascularization (TLR)

Description

Time Frame

12 months

Title

Target vessel revascularization (TVR)

Description

TVR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Time Frame

12 months

Title

Target vessel failure (TVF)

Description

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

Time Frame

12 months

Title

Death caused by other cardiovascular causes.

Description

Time Frame

12 months

Title

Rate of in-stent restenosis (ISR)

Description

Time Frame

12 months

Title

Rate of stent thrombosis (ST)

Description

Time Frame

12 months

Title

Major bleeding

Description

Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater.

Time Frame

12 months

Title

Rate of Cerebrovascular Event

Description

Compare the rate of cerebrovascular event between both groups according to Neuro-ARC stroke/ Transient ischemic attack (TIA) criteria.

Time Frame

12 months

Title

Contrast Nephropathy

Description

Creatinine increase >0.5 mg / dl or >25% over baseline at 48 hours after the procedure.

Time Frame

48 hours

Title

Technical Success

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alejandra D Portillo Romero, MD

Phone

+52 55 5573 2911

Ext

21217

aleportilloromero@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Guering Eid Lidt, MD

Phone

55 5573 2911

Ext

21217

guering@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guering Eid Lidt, MD

Organizational Affiliation

Instituto Nacional de Cardiología Ignacio Chávez

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Julio I Farjat Pasos, MD MSc

Organizational Affiliation

Instituto Nacional de Cardiología Ignacio Chávez

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Walter O Magaña Ornelas, MD

Organizational Affiliation

Instituto Nacional de Cardiología Ignacio Chávez

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alejandra D Portillo Romero, MD

Organizational Affiliation

Instituto Nacional de Cardiología Ignacio Chávez

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

José A Ayón Martínez, MD

Organizational Affiliation

Instituto Nacional de Cardiología Ignacio Chávez

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Nacional de Cardiología Ignacio Chávez

City

Mexico City

State/Province

Tlalpan

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandra D Portillo Romero, MD

Phone

+52 55 5573 2911

Ext

21217

aleportilloromero@gmail.com

First Name & Middle Initial & Last Name & Degree

Guering Edit Lid, MD

Phone

+52 55 5573 2911

Ext

21217

guering@yahoo.com

First Name & Middle Initial & Last Name & Degree

Guering Eid Lidt, MD

First Name & Middle Initial & Last Name & Degree

Julio I Farjat Pasos, MD MSc

First Name & Middle Initial & Last Name & Degree

Walter O Magaña Ornelas, MD

First Name & Middle Initial & Last Name & Degree

Alejandra D Portillo Romero, MD

First Name & Middle Initial & Last Name & Degree

José A Ayón Martinez, MD

First Name & Middle Initial & Last Name & Degree

Maria E Soto López, MD PhD

First Name & Middle Initial & Last Name & Degree

Iran Diaz Santillán, MD

First Name & Middle Initial & Last Name & Degree

Gustavo Salinas Arteaga, MD

First Name & Middle Initial & Last Name & Degree

Oscar Preciado, MD

First Name & Middle Initial & Last Name & Degree

Jorge Gaspar, MD

12. IPD Sharing Statement

Learn more about this trial

Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

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