Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Coronary Syndrome
- Coronary (Artery) Disease
- Diabetes Mellitus
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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. ...
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
Tracking Information
- NCT #
- NCT04660240
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Walther O Magaña Ornelas, M.D. Instituto Nacional de Cardiología Ignacio Chávez Study Director: Guering Eid Lidt, M.D. Instituto Nacional de Cardiología Ignacio Chávez
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