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CompletedNCT02545985Updated Sep 15, 2015

First-in-man Sirolimus-eluting Prolim® Stent Registry

An interventional study of Prolim stent deployment in Sirolimus-eluting Stainless Steel Coronary Stent Prolim®, sponsored by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sirolimus-eluting Stainless Steel Coronary Stent Prolim®

Keywords

  • sirolimus
  • coronary stent
  • Prolim
03

In context

Lead sponsor

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • inability to take dual antiplatelet therapy for 12 months,
  • left ventricular ejection fraction ≤ 30%,
  • chronic total occlusions, and
  • in-stent restenosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
204 participants (actual)

Study arms

  • Experimental
    Prolim stent implantation

    In patients with symptomatic coronary artery disease Prolim stent was implanted in coronary arteries

    Device: Prolim stent deployment

Interventions

  • DeviceProlim stent deployment

    Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.

06

What researchers measure

Primary outcomes

  1. The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).

    consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR)

    Time frame: 12 months

Secondary outcomes

  1. Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.

    Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.

    Time frame: 12 moths

  2. Late lumen loss (LLL)

    The value (in mm) of LLL assessed in qualitative coronary angiography (QCA)

    Time frame: 12 moths

  3. The percentage of covered struts assessed in optical coherence tomography (OCT)

    The percentage of covered struts assessed in OCT

    Time frame: 12 months

  4. The neointima volume assessed in OCT

    The neointima volume (in mm3) assessed in OCT

    Time frame: 12 months

  5. The device success rate

    The percentage of Prolim stents successfully implanted.

    Time frame: intraoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17869634 ↗
  • 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. PubMed 26095938 ↗
  • 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. PubMed 23257388 ↗
  • 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. PubMed 24697948 ↗
  • 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. PubMed 26573577 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02545985
Lead sponsor
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Responsible party
Jacek Bil (MD, PhD, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland) — Principal investigator
First posted
Sep 10, 2015
Start date
Jan 2013
Primary completion
Mar 2015
Completion
Jun 2015
Last update
Sep 15, 2015

Study contacts

Jacek Bil, MD, PhD
principal investigator · Central Clinical Hospital of the Ministry of Internal Affairs

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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