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

NCT ID: NCT01722799

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-04-06

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.

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug elluting Balloon (DEB)

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

Group Type: EXPERIMENTAL

Drug elluting Balloon (DEB)

Intervention Type: DEVICE

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

Drug elluting coronary stent (DES)

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.

Group Type: ACTIVE_COMPARATOR

Drug elluting coronary stent (DES)

Intervention Type: DEVICE

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Interventions

Drug elluting Balloon (DEB)

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

Intervention Type: DEVICE

Drug elluting coronary stent (DES)

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Intervention Type: DEVICE

Other Intervention Names

IN.PACT™ Falcon paclitaxel eluting balloon.; Resolute integrity™ zotarolimus drug coronary stent

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andres Iñiguez Romo, MD, PhD

OTHER_GOV

Sponsor Role: lead

Responsible Party

Andres Iñiguez Romo, MD, PhD

Dr. Andres Iñiguez Romo

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andres Iñiguez Romo, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Alvaro Cunqueiro

Victor A. Jimenez Diaz, MSC

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Alvaro Cunqueiro

Pablo M Juan Salvadores, Pharma; MPH

Role: STUDY_DIRECTOR

Hospital Universitario Alvaro Cunqueiro

Jose M. Hernández García., MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Victoria

Eduardo Molina Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de las Nieves

Francisco Bosa Ojeda, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Canarias

Armando Pérez de Prado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Leon

Fernando Lozano Ruiz-Poveda, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Ciudad Real

Cristobal A. Urbano Carrillo

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Carlos Haya

Locations

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 20081769 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20948503 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19487593 (View on PubMed)

Related Links

http://www.cardiologia-vigo.com

Web Page from Cardiology department.Hospital Meixoeiro.

Other Identifiers

RAMSES-DEB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MEIX-STENT-001

Identifier Type: -

Identifier Source: org_study_id