revascularization

IN-PACT CORO: OCT validation of drug-eluting balloons

Drug-eluting balloons could reduce intimal hyperplasia detected by OCT in intmerventions with conventional stents. 30 patients were randomized into 3 groups: 10 patients received conventional stents, 10 patients received a drug-eluting balloon prior to the conventional stent, and 10 patients receive a drug-eluting balloon after the conventional stent. We performed angiographic and OCT follow-up at...

ORBIT II: new atherectomy device

The objective of the study was to test the use of a new atherectomy device to prepare severely calcified lesions. It was an observational, prospective, multicenter study that included 443 patients from 49 sites with a 30-day follow-up. The lesion was classified as severely calcified, as fluoroscopy showed the presence of calcium on both sides...

J- REVERSE: sirolimus-eluting vs. everolimus-eluting stent in bifurcation lesions

Asymmetrical expansion of the stent produces an uneven neointimal growth and increases the risk of thrombosis. The study was divided into two parts: the first one aimed at comparing, in the acute phase and the medium term, the result of provisional bifurcation stenting technique with sirolimus-eluting stent vs everolimus-eluting stent (both guided by IVUS); the...

EXPAND: expanding the applications of bioresorbable platforms

There is little information about the use of bioresorbable vascular devices in patients with a reference diameter ≥4mm, long, bifurcation, calcified or unstable lesions. The BVS-Expand registry is a single-center study that evaluates the safety and efficacy of this device in past populations (real world).The primary endpoint was the occurrence of MACE (cardiac death, myocardial...

DIRECT: results of drug-eluting stent-on-a-wire after 6 months

This balloon expandable stent is combined with a guide 0.014 in its distal part. The platform is made of cobalt chrome and the polymer is bio-degradable. 30 patients were included prospectively and there was angiographic follow-up with IVUS and OCT after 6 months. The reference vessel diameter was 2.69 mm ± 0.48, with a length...

BIOSS: results of the new drug-eluting stent for bifurcations

This new device is a stainless steel platform of 120 µm thick with a sirolimus-eluting bio-absorbable polymer. It has two separate parts: a larger diameter proximal part and a smaller diameter distal part connected by two 1.2 mm structures. The objective of this study was to test (first in man) the device in bifurcations. We...

BIOFLOW II. Stent eluidor de sirolimus com polímero degradável.

This non-inferiority design study compared the sirolimus-eluting stent with biodegradable polymer versus everolimus-eluting stent with permanent polymer in de novo coronary lesions. The primary endpoint was late lumen loss at nine months. We Included 440 patients with stable coronary lesions randomized 2:1 to receive the new sirolimus eluting stent with biodegradable polymer versus everolimus eluting...

SYNTAX II: multiple vessels using iFR / FFR and IVUS

This study is still in progress and includes patients using SYNTAX II score based on functional invasive evaluation with iFR / FFR and performing angioplasty guided by IVUS using the biodegradable polymer everolimus eluting stent. The study seeks to prove superiority versus the first generation paclitaxel-eluting stent and non-inferiority versus surgery using historical data. We...

DESolveNx trial: Results of the new bioabsorbable platform

This new device consists of a novolimus releasing bioabsorbable polylactic acid platform that in vitro studies has shown equivalence to a Cypher stent. This device, also in vitro , showed a degradation time of one year and safety during post expansion, reaching 4.8 mm without fracturing. This is the first human trial and follow-up with...

SMART-CASE: Angiographic Guidanceangioplastyto >50% versus >70% lesions.

This prospective randomized study compared aggressive revascularization angiography injuries 50% versus a most conservative revascularization lesions>70%.The primary end point was death, myocardial infarction and recurring revascularization. We included a total of 889 patients (449 in the aggressive revascularization group and 450 in the conservative revascularization group).No differences in major cardiac events between the two groups...

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