Diabetes MellitusINC-DMNCT04660240
Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus
A study testing Abluminus Sirolimus Eluting Stent System (ASES) and Orsiro Sirolimus Eluting Coronary Stent System (OSES) in people with Diabetes Mellitus and Coronary Artery Disease, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Abluminus Sirolimus Eluting Stent System (ASES) and Orsiro Sirolimus Eluting Coronary Stent System (OSES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2020to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Tlalpan, 14080
Alejandra D Portillo Romero, MD, +52 55 5573 2911 ext. 21217, aleportilloromero@gmail.com
Guering Edit Lid, MD, +52 55 5573 2911 ext. 21217, guering@yahoo.com
About this study
Official title: Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus
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.
Read the 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
- Being tested
- Abluminus Sirolimus Eluting Stent System (ASES), Orsiro Sirolimus Eluting Coronary Stent System (OSES)
- Keywords
- Diabetes Mellitus, Albuminus, Orsiro, Percutaneous coronary intervention
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Abluminus Sirolimus Eluting Stent System (ASES) | Active comparator | The Abluminus sirolimus eluting stent manufactured by Envision and distributed by Concept Medical. Receives: Device: Abluminus Sirolimus Eluting Stent System (ASES) |
| Orsiro Sirolimus Eluting Coronary Stent System (OSES) | Experimental | The Orsiro sirolimus eluting stent manufactured by Biotronik. Receives: Device: Orsiro Sirolimus Eluting Coronary Stent System (OSES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (12)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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)
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
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).
Measured: 12 months
Major bleeding
Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater.
Measured: 12 months
Rate of Cerebrovascular Event
Compare the rate of cerebrovascular event between both groups according to Neuro-ARC stroke/ Transient ischemic attack (TIA) criteria.
Measured: 12 months
Contrast Nephropathy
Creatinine increase >0.5 mg / dl or >25% over baseline at 48 hours after the procedure.
Measured: 48 hours
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Oct 2020
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Ivan Farjat Pasos, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Guering Eid Lidt, MD, Study director, Instituto Nacional de Cardiología Ignacio ChávezJulio I Farjat Pasos, MD MSc, Principal investigator, Instituto Nacional de Cardiología Ignacio ChávezWalter O Magaña Ornelas, MD, Principal investigator, Instituto Nacional de Cardiología Ignacio ChávezAlejandra D Portillo Romero, MD, Principal investigator, Instituto Nacional de Cardiología Ignacio ChávezJosé A Ayón Martínez, MD, Principal investigator, Instituto Nacional de Cardiología Ignacio Chávez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660240
- Sponsor's protocol ID
- INCAR-DG-DI-342-2020
- Acronym
- INC-DM
- Status last verified
- Feb 2024
- First submitted
- 3 Dec 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04660240
- Acronym / sponsor ID
- INC-DM / INCAR-DG-DI-342-2020
- Keywords
- Diabetes Mellitus, Albuminus, Orsiro, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Abluminus Sirolimus Eluting Stent System (ASES) | Active comparator | Device: Abluminus Sirolimus Eluting Stent System (ASES)The Abluminus sirolimus eluting stent manufactured by Envision and distributed by Concept Medical. |
| Orsiro Sirolimus Eluting Coronary Stent System (OSES) | Experimental | Device: Orsiro Sirolimus Eluting Coronary Stent System (OSES)The Orsiro sirolimus eluting stent manufactured by Biotronik. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abluminus Sirolimus Eluting Stent System (ASES)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. | Device | Abluminus Sirolimus Eluting Stent System (ASES) |
| Orsiro Sirolimus Eluting Coronary Stent System (OSES)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. | Device | Orsiro Sirolimus Eluting Coronary Stent System (OSES) |
Primary outcome
Rate of Target Lesion Failure (TLF)
Time frame: 12 months
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 secondary outcomes
Cardiovascular Death
Time frame: 12 months
Myocardial Infarction (MI)
Time frame: 12 months
Target Lesion Revascularization (TLR)
Time frame: 12 months
Target vessel revascularization (TVR)
Time frame: 12 months
Target vessel failure (TVF)
Time frame: 12 months
Death caused by other cardiovascular causes.
Time frame: 12 months
Rate of in-stent restenosis (ISR)
Time frame: 12 months
Rate of stent thrombosis (ST)
Time frame: 12 months
Major bleeding
Time frame: 12 months
Rate of Cerebrovascular Event
Time frame: 12 months
Contrast Nephropathy
Time frame: 48 hours
Technical Success
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guering Eid Lidt, MD study director
Instituto Nacional de Cardiología Ignacio Chávez
Julio I Farjat Pasos, MD MSc principal investigator
Instituto Nacional de Cardiología Ignacio Chávez
Walter O Magaña Ornelas, MD principal investigator
Instituto Nacional de Cardiología Ignacio Chávez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abluminus Sirolimus Eluting Stent System (ASES) and Orsiro Sirolimus Eluting Coronary Stent System (OSES) in people with Diabetes Mellitus and Coronary Artery Disease, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandra D Portillo Romero, MD (+52 55 5573 2911 ext. 21217, aleportilloromero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.