BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)

NCT03475563 | Unknown

• 1 other identifier: BIOSS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stent; Dedicated bifurcation stent; Cobalt-chromium; Sirolimus-eluting stent

Outcome Measures

Primary Outcomes (3)

• Successful angioplasty

  After angiography: TIMI (thrombolysis in myocardial infarction ) 3 (both branches). With respect to reference diameter, none of the segments treated with stent has a residual stenosis\> 30% or\> 50% in those not treated with stent.

  1 day

• MACE

  Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)

  30 days

• MACE

  Cumulative rate of major adverse cardiovascular events (MACE) including cardiac

  1 year

Secondary Outcomes (4)

• Target vessel revascularization

  30 days

• Percentage of stent struts malposition

  30 days

• contrast media volume

  1 day

• Angioplasty time

  1 day

Study Arms (1)

Patients with coronary artery disease

(coronary artery disease)

Procedure: Coronary angioplasty with stent implantation

Interventions

Coronary angioplasty with stent implantation PROCEDURE

Coronary angioplasty with BiOSS LIM C stent implantation

Patients with coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic heart disease referred for coronary revascularization will be included with susceptible lesion of coronary intervention in bifurcation.

You may qualify if:

• Age over 18 years.
• Clinical indication of coronary angioplasty in bifurcated lesion.
• Bifurcated lesions with both distal branches at least 2 mm in diameter.
• The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
• Express acceptance and signature of informed consent.

You may not qualify if:

• Express rejection of the patient to participate in the study.
• Exclusive involvement of the lateral branch (Medina lesion 001).
• Contraindication for antiplatelet treatment.
• Lesions due to restenosis.
• Lesions in saphenous grafts.
• Total chronic occlusions.
• Cardiogenic shock.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (3)

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de León

León, 24071, Spain

RECRUITING

Related Publications (3)

• Gil RJ, Bil J, Dzavik V, Vassilev D, Kern A, Formuszewicz R, Zalewska-Adamiec M, Dobrzycki S. Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial. Can J Cardiol. 2015 May;31(5):671-8. doi: 10.1016/j.cjca.2014.12.024. Epub 2014 Dec 24.

  PMID: 25828372 RESULT

• Gil RJ, Bil J, Vassiliev D, Inigo Garcia LA. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM(R) Registry. J Interv Cardiol. 2015 Feb;28(1):51-60. doi: 10.1111/joic.12180.

  PMID: 25689548 RESULT

• Gil RJ, Bil J, Grundeken MJ, Inigo Garcia LA, Vassilev D, Kern A, Pawlowski T, Wykrzykowska JJ, Serruys PW. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM(R) dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. EuroIntervention. 2016 Nov 20;12(10):1246-1254. doi: 10.4244/EIJY15M10_05.

  PMID: 26465375 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Imanol Otaegui, MD

  Hospital Universitari Vall d'hebron Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imanol Otaegui, MD

CONTACT

+342746155; iotaegui@vhebron.net

Imanol Otaegui

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: August 16, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

ES (3)