NCT02545985

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

August 30, 2015

Last Update Submit

September 12, 2015

Conditions

Sirolimus-eluting Stainless Steel Coronary Stent Prolim®

Keywords

sirolimuscoronary stentProlim

Outcome Measures

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)

    12 months

Secondary Outcomes (5)

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

    12 moths

  • Late lumen loss (LLL)

    12 moths

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

    12 months

  • The neointima volume assessed in OCT

    12 months

  • The device success rate

    intraoperative

Study Arms (1)

Prolim stent implantation

EXPERIMENTAL

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

Device: Prolim stent deployment

Interventions

Prolim stent deploymentDEVICE

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

Prolim stent implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 17869634RESULT

  • 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.

    PMID: 26095938RESULT

  • 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.

    PMID: 23257388RESULT

  • 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.

    PMID: 24697948RESULT

  • 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.

    PMID: 26573577DERIVED

Study Officials

  • Jacek Bil, MD, PhD

    Central Clinical Hospital of the Ministry of Internal Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 30, 2015

First Posted

September 10, 2015

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

September 15, 2015

Record last verified: 2015-09