Clinical trial NCT02545985: First-in-man Sirolimus-eluting Prolim® Stent Registry
Official title: Novel Sirolimus-eluting Stent Prolim® With a Biodegradable Polymer in the All-comers Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sirolimus-eluting Stainless Steel Coronary Stent Prolim®
Keywords: sirolimus
coronary stent
Prolim
Lead sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.

Detailed description: Investigators prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome, treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15% of patients (randomly chosen) underwent optical coherence tomography analysis. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization after 12 months.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old,
* stable coronary artery disease (SCAD) or acute coronary syndrome (unstable angina - UA, non-ST elevation myocardial infarction - NSTEMI or ST-elevation myocardial infarction - STEMI) and
* signed informed consent

Exclusion Criteria:

* inability to take dual antiplatelet therapy for 12 months,
* left ventricular ejection fraction ≤ 30%,
* chronic total occlusions, and
* in-stent restenosis

Primary outcomes:
measure: The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
timeFrame: 12 months
Secondary outcomes:
measure: Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.
timeFrame: 12 moths
measure: Late lumen loss (LLL)
timeFrame: 12 moths
measure: The percentage of covered struts assessed in optical coherence tomography (OCT)
timeFrame: 12 months
measure: The neointima volume assessed in OCT
timeFrame: 12 months
measure: The device success rate
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Central Clinical Hospital of the Ministry of Internal Affairs
name: Jacek Bil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
citation: Lavi S, Dzavik V. Biodegradable Stent Platforms: Are We Heading in the Right Direction? Can J Cardiol. 2015 Aug;31(8):957-9. doi: 10.1016/j.cjca.2015.04.005. Epub 2015 Apr 14. No abstract available.
citation: Nagoshi R, Shinke T, Otake H, Shite J, Matsumoto D, Kawamori H, Nakagawa M, Kozuki A, Hariki H, Inoue T, Ohsue T, Taniguchi Y, Iwasaki M, Nishio R, Hiranuma N, Konishi A, Kinutani H, Miyoshi N, Takaya T, Yamada S, Yasaka Y, Hayashi T, Yokoyama M, Kato H, Kadotani M, Ohnishi Y, Hirata K. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents. Circ J. 2013;77(3):652-60. doi: 10.1253/circj.cj-12-0610. Epub 2012 Dec 21.
citation: Zhang Q, Qiu JP, Kirtane AJ, Zhu TQ, Zhang RY, Yang ZK, Hu J, Ding FH, DU R, Shen WF. Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study. J Interv Cardiol. 2014 Apr;27(2):131-41. doi: 10.1111/joic.12102.
citation: Bil J, Gil RJ, Kern A, Pawlowski T, Seweryniak P, Sliwinski Z. Novel sirolimus-eluting stent Prolim(R) with a biodegradable polymer in the all-comers population: one year clinical results with quantitative coronary angiography and optical coherence tomography analysis. BMC Cardiovasc Disord. 2015 Nov 14;15:150. doi: 10.1186/s12872-015-0139-5.