DESTINY TRIAL (Inspiron x Biomatrix)

NCT01856088 | Completed Phase 4 DMC

• 1 other identifier: Scitech 004
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 10

Brief Summary

The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.

Conditions

Coronary Artery Disease

Keywords

Coronary artery; Drug eluting stent; thrombosis

Outcome Measures

Primary Outcomes (1)

• Lumen Loss

  For an accurate assessment of the stent conditions 9 months after implantation, a follow-up catheterization will be performed at the 9 months visit in order to measure the diameter of the artery at the stented site. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months.

  9 months after the procedure

Secondary Outcomes (1)

• Adverse Cardiac Events

  30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.

Study Arms (2)

Inspiron Stent

EXPERIMENTAL

Stent Inspiron with Sirolimus

Device: Inspiron Stent

Biomatrix Flex Stent

ACTIVE COMPARATOR

Stent Biomatrix Flex with biolimus

Device: Biomatrix Flex Stent

Interventions

Inspiron Stent DEVICE

stent implantation

Also known as: Angioplasty

Inspiron Stent

Biomatrix Flex Stent DEVICE

stent implantation

Also known as: Angioplasty

Biomatrix Flex Stent

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years;
• Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels;
• A(s) lesion(s) to target(m) must be:
• Again (not restenotic);
• Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual);
• Can be treated with a single stent up to 29 mm in length;
• Obstruction with stenosis \> 50% diameter (visual);
• Acceptable candidate for CABG;
• The patient will be informed of the nature of the study, agree with their rules and provide a written informed consent approved by the local Ethics Committee.

You may not qualify if:

• Women of childbearing age with no history of surgical sterilization;
• Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure;
• Myocardial infarction with or without Q wave with cardiac markers even at high levels;
• Ejection fraction \< 30%;
• Impaired renal function (creatinine\> 2.0 mg / dl) or calculated creatinine clearance \< 60 ml / min;
• Platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3;
• Total leukocyte count \<3000 cells/mm3;
• Documented or suspected liver disease (including laboratory evidence of hepatitis);
• Heart transplant recipient;
• Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel;
• Patient with a life expectancy less than 12 months;
• Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study;
• Participation in other research in the last 12 months, unless there is direct benefit to the research subject;
• Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel;
• Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion;

Sponsors & Collaborators

• Scitech Produtos Medicos Ltda: lead

Study Sites (10)

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

Location

Encore - Cardiologia e Radiologia Intervencionista

Goiânia, Goiás, Brazil

Location

Hospital Cardiologico Costantini

Curitiba, Paraná, Brazil

Location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Bandeirantes de São Paulo

São Paulo, São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

Location

Instituto de Assistência Médica ao Servidor Publico Estadual

São Paulo, São Paulo, Brazil

Location

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Location

Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

Location

Hospital Santa Marcelina

São Paulo, Brazil

Location

Related Publications (1)

• Lemos PA, Abizaid AA, Meireles GC, Sarmento-Leite R, Prudente M, Cantarelli M, Dourado AD, Mariani J Jr, Perin MA, Costantini C, Costa RA, Costa JR, Chamie D, Campos CA, Ribeiro E. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial. Cardiovasc Ther. 2015 Dec;33(6):367-71. doi: 10.1111/1755-5922.12159.

  PMID: 26352896 DERIVED

Related Links

• Sponsor site
• National Information System on Ethics in Research Involving Human

MeSH Terms

Conditions

Coronary Artery Disease; Thrombosis

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pedro Lemos

  Instituto do Coração - Incor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: March 21, 2019
• Last Updated: March 25, 2019

Record last verified: 2018-04

Locations

BR (10)