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

Coronary Disease Clinical Trial

— RAMSES  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722799
• Other study ID #: MEIX-STENT-001
• Secondary ID: RAMSES-DEB
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: April 6, 2018

Study information

• Verified date: August 2018
• Source: Hospital de Meixoeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 6, 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Drug elluting Balloon (DEB)
Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.
• Drug elluting coronary stent (DES)
Percutaneous transluminal coronary angioplasty (PTCA) with stent

Locations

Country	Name	City	State
Spain	Hospital Universitario Álvaro Cunqueiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Andres Iñiguez Romo, MD, PhD

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Review. — View 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. Review. — View 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 st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	In order to perform a cost-utility analysis, years of quality-adjusted life (QALY) gained will be measured using the quality of life questionnaire EuroQoL five dimensions (EQ-5D) and a visual scale at baseline, one month and 12 months.	The efficiency will be evaluated at first month, 6 month and 1 year.
Secondary	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.

External Links

•   Web Page from Cardiology department.Hospital Meixoeiro.