News | May 21, 2007

XTENT DES Fares Well at Six Months in Difficult-to-Treat Population

May 23, 2007 — XTENT Inc. announced positive six-month follow-up data from the CUSTOM II clinical trial, which assessed the safety and efficacy of the company's investigational Custom NX drug-eluting stent (DES) system for the treatment of long and multiple lesions in patients with coronary artery disease. Results were presented during the EuroPCR Meeting taking place this week in Barcelona.

The single-arm prospective study evaluated the use of CUSTOM NX in patients with long lesions, defined as greater than 20mm, and patients with two lesions. Of the 100 patients enrolled, 69 patients were enrolled in the long lesion arm, and 31 patients were enrolled in the two-lesion arm of the study.

Up to two customizable stent deployments of up to 60mm total length were evaluated in the study. The primary endpoint was Major Adverse Cardiac Events (MACE) at six months, with clinical follow-up at one, six and 12 months, then annually for five years. Angiographic and intravascular ultrasound (IVUS) follow-up was conducted at six months. The anticoagulation regimen was clopidogrel for a minimum of three months plus aspirin.

At six-month follow-up, the MACE rate was 9 percent. Early adverse events (in hospital) occurred in five patients, including four myocardial infarctions and one death. At six months, four additional patients (4 percent) underwent target lesion revascularization. Angiographic and IVUS results demonstrated in-stent late loss was 0.31mm; in-segment late loss was 0.22mm; binary restenosis rate was 7.5 percent; and the percentage of neointimal volume was 3.3 percent.

"These data are particularly encouraging considering CUSTOM II enrolled one of the most difficult-to-treat patient populations ever studied in a DES trial and also mirrored the complex disease profile physicians are most likely to see among patients presenting today with coronary artery disease," said Professor Eberhard Grube, MD, chief of cardiology at the Helios Heart Center in Siegburg, Germany and principal investigator of the CUSTOM II trial, who presented the data at the annual EuroPCR meeting in Barcelona. "Despite the complexity of patients treated, the Custom NX system allowed for very favorable results."

In the CUSTOM II patient population, the average vessel diameter was 2.57mm and the average lesion length was 28.7mm. Of the 100 patients enrolled in the trial, 26 percent were diabetic. The percentage of patients with ACC/AHA lesion grade B2 or C was 65.1 percent. This trial includes a high percentage of patients with complex lesions and one of the longest average lesion lengths studied of any DES clinical trial.

For more information visit www.xtentinc.com.

Related Content

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS) bioabsorbable stent.

The Abbott Absorb Bioresorbable Vascular Scaffold (BVS).

Feature | Stents Drug Eluting| January 17, 2018 | Dave Fornell
There was no shortage of interest in bioresorbable stent technologies at the many sessions offered on this topic or b
Cordis and Medinol Announce FDA Approval of EluNIR Drug-Eluting Stent System
Technology | Stents Drug Eluting| December 13, 2017
Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) approval of...
The Xience Sierra stent.
Technology | Stents Drug Eluting| November 09, 2017
November 9, 2017 — Abbott received European CE mark for Xience Sierra, the newest generation of the company's Xience
Synergy Stent With Shorter DAPT Superior to Bare-Metal Stent in Elderly Patients
News | Stents Drug Eluting| November 06, 2017
November 6, 2017 — Elderly patients undergoing...
Biotronik Orsiro DES Shows Low Five-Year Event Rates
News | Stents Drug Eluting| November 03, 2017
November 3, 2017 — Biotronik's Orsiro...
Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

Image courtesy of OrbusNeich

News | Stents Drug Eluting| November 01, 2017
OrbusNeich reported results from the REDUCE trial in the Late-Breaking Clinical Trial session at the 29th annual...
News | Stents Drug Eluting| October 25, 2017
Elixir Medical Corp. announced it will unveil a new metallic drug-eluting stent (DES) platform at this year’s...
Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
News | Stents Drug Eluting| September 01, 2017
September 1, 2017 — Biotronik recently announced data from the BIOFLOW-V randomized trial comparing Orsiro and Xience
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Overlay Init