Back to results

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

Primary Purpose

Coronary Disease

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Drug elluting Balloon (DEB)

Drug elluting coronary stent (DES)

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring angioplasty, Percutaneous Transluminal Coronary Angioplasty, Drug elluting Balloon, Coronary Balloon, Dilatation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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,
1 year FU not guaranteed,
Being participating in another study.

Sites / Locations

Hospital Universitario Álvaro Cunqueiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug elluting Balloon (DEB)

Drug elluting coronary stent (DES)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT01722799

First Posted

September 25, 2012

Last Updated

August 1, 2018

Sponsor

Andres Iñiguez Romo, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT01722799

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

December 2012 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

April 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andres Iñiguez Romo, MD, PhD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug elluting Balloon (DEB)

Arm Type

Experimental

Arm Description

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

Arm Title

Drug elluting coronary stent (DES)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Drug elluting Balloon (DEB)

Other Intervention Name(s)

IN.PACT™ Falcon paclitaxel eluting balloon.

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Drug elluting coronary stent (DES)

Other Intervention Name(s)

Resolute integrity™ zotarolimus drug coronary stent

Intervention Description

Percutaneous transluminal coronary angioplasty (PTCA) with stent

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

The efficacy will be evaluated at 1 year.

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Description

Time Frame

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

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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, 1 year FU not guaranteed, Being participating in another study.

Overall Study Officials: