A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients

Seth, Ashok; Chandra, Praveen; Chouhan, Nagendra; Thakkar, Ashok

doi:10.1016/j.ihj.2012.07.011

Cited by 16 publications

(12 citation statements)

References 31 publications

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“…The technical and procedural success of sirolimus-eluting stent as well as late loss and restenosis rate can be improved by the use of Co-Cr as stent platform. Supralimus-Core ® stent has a strut thickness of 60 mm (thin strut) which is also likely to improve long-term angiographic result as shown in MAXIMUS study [16]. Supralimus-Core ® stents' clinical effectiveness and safety was initially demonstrated in MAXIMUS study (The first-in-man study of sirolimus-eluting, biodegradable polymer coated Co-Cr Stent).…”

Section: Discussionmentioning

confidence: 97%

“…Ltd., Surat, India) uses L605 Co-Cr alloy as its stent platform which is coated with a biodegradable polymer to deliver sirolimus. Supralimus-Core ® stent system proved its effectiveness by reducing restenosis at 8 months and safety with an acceptable rate of cardiac events at 12 months [16]. The primary objective of the present registry was to assess the safety and efficacy of the Supralimus-Core ® sirolimus-eluting stent (SES) deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent.…”

Section: Introductionmentioning

confidence: 99%

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Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

Chandwani¹,

Abhyankar²,

Prajapati³

et al. 2014

IJCM

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OBJECTIVE: The primary objective of the SCORE registry was to assess the safety and efficacy of the Supralimus-Core ® sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: SCORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in which 562 patients undergoing single-or multi-vessel percutaneous coronary intervention were enrolled. The pre-specified primary outcome was the rate of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) at 12-month post-procedure. Stent thrombosis (ST) served as the safety endpoint. RESULTS: A total of 640 lesions were treated in 562 enrolled patients (mean age 57.4 ± 10.7 years) with average stent length of 25.0 ± 9.0 mm. Stent delivery was successful in 99% cases. A total of 554 (98.6%) patients have been followed up to 12 months. The incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%) respectively. The composite rate of MACE at a 12-month clinical follow-up was 19 (3.4%), consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. The long-term follow-up of this registry is going on to confirm safety and efficacy profiles. CONCLUSIONS: This multicenter registry demonstrated satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events up to 12 months, for the cobalt-chromium biodegradable polymer-based sirolimus-eluting Supralimus-Core ® stent in a "real-world" setting.

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Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

Chandwani¹,

Abhyankar²,

Prajapati³

et al. 2014

IJCM

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“…The Supralimus-Core (Sahajanand Medical Technologies) is a clinically proven sirolimus-eluting coronary stent and its safety and efficacy has demonstrated in real-life patients. 24 25 The Supraflex SES is a further improved version of the Supralimus-Core SES with replacement of the rigid interlink/joint of the Supralimus-Core SES with a highly flexible 'S-link', which increases flexibility and deliverability of the Supraflex SES. Additionally, in the S-CORE Registry (multicentre registry of Supralimus-Core biodegradable polymer SES), which enrolled 562 'realworld' patients, the incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%), respectively.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Lemos

Chandwani²,

Saxena

et al. 2016

BMJ Open

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ObjectivesTo evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis.SettingMulticentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India.Participants995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up.InterventionsPercutaneous coronary intervention with Supraflex SES,Primary and secondary outcome measuresThe primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months.ResultsAt 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm.ConclusionsThe FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

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“…From CTRI, I found there were 30 coronary stent clinical trials registered to date and a total of 13,934 patients involved in research. [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] From the registered trials data set, it is evident that:…”

Section: Discussionmentioning

confidence: 99%

Clinical Trials of Coronary Stents in India: An Update

Prashanth¹

2016

Heart Res Open J

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A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients

Abstract: This study demonstrates that the Supralimus-Core® SES is a safe and effective treatment for patients with obstructive coronary artery disease. ClinicalTrials.gov ID: NCT00811616.

Cited by 16 publications

References 31 publications

Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Clinical Trials of Coronary Stents in India: An Update

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