Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.

NCT01722799 | Completed DMC

• 2 other identifiers: MEIX-STENT-001RAMSES-DEB
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization remains the main limitation, representing a challenging problem even in the DES (drug eluting stent) era. Recently has been developed drug eluting balloons (DEBs), which have been successfully tested in small series on in-stent restenosis, but few evidence is available in the context of small vessels disease. The current study has been designed to know, in one hand, the clinical efficacy of the Drug elluting balloon IN.PACT FALCON and, in other hand, the effectiveness, and the cost-effectiveness incremental analysis of DEBs (IN.PACT FALCON vs. DES ( RESOLUTE INTEGRITY) in patients with de novo lesions in small vessels.

Conditions

Coronary Disease

Keywords

angioplasty; Percutaneous Transluminal Coronary Angioplasty; Drug elluting Balloon; Coronary Balloon; Dilatation

Outcome Measures

Primary Outcomes (2)

• Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).

  Target vessel failure (TVF) is define as any revascularization motivated due to myocardial infarction (with or without Q wave) or cardiac death related to the target vessel.

  The efficacy will be evaluated at 1 year.

• Compare the clinical security measured by the incidence MACE of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).

  Rate of major adverse cardiac events (MACE) at 30 days, 6 months and one year. MACE was defined as cardiac death, myocardial infarction (MI) (with or without Q-wave), need for repeat revascularization of the treated vessel (surgical or repeat PCI) or occlusion of the treated lesion.

  The security will be evaluated at one month, sixth month and one year

Secondary Outcomes (2)

• Compare the efficiency of DEBs versus DES. in terms of cost effectiveness (cost per adverse event-death avoided) and cost-utility ( cost per quality adjusted life year) in patients with de novo lesions in small vessels.

  The efficiency will be evaluated at first month, 6 month and 1 year.

• Compare the direct cost, indirect costs and total costs of DEBs versus DES in patients with de novo lesions in small vessels.

  This outcome will be evaluated at first month, 6 month and 1 year.

Study Arms (2)

Drug elluting Balloon (DEB)

EXPERIMENTAL

Is a coronary dilating device with Paclitaxel ® drug delivery, for dilatation and provisional spot bare metal stenting (BMS).

Device: Drug elluting Balloon (DEB)

Drug elluting coronary stent (DES)

ACTIVE COMPARATOR

The Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm.

Device: Drug elluting coronary stent (DES)

Interventions

Drug elluting Balloon (DEB) DEVICE

Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.

Also known as: IN.PACT™ Falcon paclitaxel eluting balloon.

Drug elluting Balloon (DEB)

Drug elluting coronary stent (DES) DEVICE

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Also known as: Resolute integrity™ zotarolimus drug coronary stent

Drug elluting coronary stent (DES)

Eligibility Criteria

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

You may qualify if:

• Older than 18, informed consent.
• Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or \>50% by CT scan); affecting
• Vessels between 2,25 and 2,75 mm diameter and
• The length of the coronary stenosis ≤25 mm
• Patient informed consent form signed.

You may not qualify if:

• Lesion in coronary left main ,
• Chronic total occlusions,
• Lesions at bifurcation,
• Severe calcified lesions,
• Lesions in aorto-coronary saphenous veins or arterial grafts,
• Acute Myocardial Infarction during 48 hours before the procedure,
• Severe renal dysfunction,
• Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
• Allergy to contrast media,
• Life expectancy less than 1 year,
• year FU not guaranteed,
• Being participating in another study.

Sponsors & Collaborators

• Andres Iñiguez Romo, MD, PhD: lead

Study Sites (1)

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Related Publications (3)

• Tepe G, Schmitmeier S, Speck U, Schnorr B, Kelsch B, Scheller B. Advances on drug-coated balloons. J Cardiovasc Surg (Torino). 2010 Feb;51(1):125-43.

  PMID: 20081769 RESULT

• Schnorr B, Kelsch B, Cremers B, Clever YP, Speck U, Scheller B. Paclitaxel-coated balloons - Survey of preclinical data. Minerva Cardioangiol. 2010 Oct;58(5):567-82.

  PMID: 20948503 RESULT

• Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

  PMID: 19487593 RESULT

Related Links

• Web Page from Cardiology department.Hospital Meixoeiro.

MeSH Terms

Conditions

Coronary Disease; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andres Iñiguez Romo, MD,PHD

  Hospital Universitario Alvaro Cunqueiro

  PRINCIPAL INVESTIGATOR

• Victor A. Jimenez Diaz, MSC

  Hospital Universitario Alvaro Cunqueiro

  PRINCIPAL INVESTIGATOR

• Pablo M Juan Salvadores, Pharma; MPH

  Hospital Universitario Alvaro Cunqueiro

  STUDY DIRECTOR

• Jose M. Hernández García., MD

  Hospital Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

• Eduardo Molina Navarro, MD

  Hospital Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

• Francisco Bosa Ojeda, MD

  Complejo Hospitalario Universitario de Canarias

  PRINCIPAL INVESTIGATOR

• Armando Pérez de Prado, MD

  Hospital Universitario de Leon

  PRINCIPAL INVESTIGATOR

• Fernando Lozano Ruiz-Poveda, MD

  Hospital Universitario de Ciudad Real

  PRINCIPAL INVESTIGATOR

• Cristobal A. Urbano Carrillo

  Hospital Clínico Universitario Carlos Haya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Andres Iñiguez Romo

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: November 7, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: April 6, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

ES (1)