Clinical trial NCT01722799: Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.
Official title: PROSPECTIVE RANDOMIZED TRIAL Multicentric Study to Evaluate the Treatment and the Efficiency of Paclitaxel-coated Balloon IN.PACT FALCON ® in Small-vessel Coronary Stenosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: angioplasty
Percutaneous Transluminal Coronary Angioplasty
Drug elluting Balloon
Coronary Balloon
Dilatation
Lead sponsor: Hospital de Meixoeiro
Sponsor class: OTHER_GOV
First posted: 2012-11-07
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting neointimal proliferation, and thus the limitation of restenosis, which has led to the conception and development of drug-coated balloon or "Drug Eluting Balloons" (DEB), releasing the antiproliferative drug at the time of expansion. Initially they were applied in the treatment of in-stent restenosis. However, DEB may represent a therapeutic alternative in other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary revascularization with stent implantation, as is the case of coronary lesions located in small vessels.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Lesion in coronary left main ,
2. Chronic total occlusions,
3. Lesions at bifurcation,
4. Severe calcified lesions,
5. Lesions in aorto-coronary saphenous veins or arterial grafts,
6. Acute Myocardial Infarction during 48 hours before the procedure,
7. Severe renal dysfunction,
8. Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
9. Allergy to contrast media,
10. Life expectancy less than 1 year,
11. 1 year FU not guaranteed,
12. Being participating in another study.

Primary outcomes:
measure: Compare the clinical efficacy measured by target vessel failure of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).
timeFrame: The efficacy will be evaluated at 1 year.
measure: Compare the clinical security measured by the incidence MACE of DEB IN.PACT FALCON DEB versus the resolute integrity stent (DES).
timeFrame: The security will be evaluated at one month, sixth month and one year
Secondary outcomes:
measure: 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.
timeFrame: The efficiency will be evaluated at first month, 6 month and 1 year.
measure: Compare the direct cost, indirect costs and total costs of DEBs versus DES in patients with de novo lesions in small vessels.
timeFrame: This outcome will be evaluated at first month, 6 month and 1 year.
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Universitario Álvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Hospital Universitario Alvaro Cunqueiro
name: Andres Iñiguez Romo, MD,PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Alvaro Cunqueiro
name: Victor A. Jimenez Diaz, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Alvaro Cunqueiro
name: Pablo M Juan Salvadores, Pharma; MPH
role: STUDY_DIRECTOR
affiliation: Hospital Virgen de la Victoria
name: Jose M. Hernández García., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de las Nieves
name: Eduardo Molina Navarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Canarias
name: Francisco Bosa Ojeda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Leon
name: Armando Pérez de Prado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Ciudad Real
name: Fernando Lozano Ruiz-Poveda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Carlos Haya
name: Cristobal A. Urbano Carrillo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.