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

Andres Iñiguez Romo, MD, PhD

Status: Completed

Conditions: Coronary Disease

Treatments: Device: Drug elluting coronary stent (DES); Device: Drug elluting Balloon (DEB)

Study type: Interventional

Funder types: Other

Identifiers

NCT01722799

RAMSES-DEB (Other Grant/Funding Number)

MEIX-STENT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Drug elluting Balloon (DEB)

Experimental group

Description:

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

Treatment:

Device: Drug elluting Balloon (DEB)

Drug elluting coronary stent (DES)

Active Comparator group

Description:

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.

Treatment:

Device: Drug elluting coronary stent (DES)