ABILITY RCT

A Randomized clinical trial of Abluminus DES+ versus Xience Everolimus-Eluting Stent for Percutaneous Coronary Intervention in patients with Diabetes Mellitus:

An Investigator-Initiated Pilot Study 

1. Parts of both stent and balloon are coated
The stent is been coated in a pre-crimped condition and hence both the stent as well as balloon are coated to enhance drug delivery area

2. Treatment of Diffused Lesion and Focal Restenosis
The most complex lesions are been addressed because of the burst release of drug (Balloon) and Programmed release of drug (Stent).

3. Abluminal Coating
The coating is on the abluminal side of the stent which helps in faster re-endothelialization.

4. Hybrid Stent
The stent has a hybrid design platform which comprises of open cells in the mid segment while closed cells at the edge. Hence, has also better bifurcation access area.

5.Thin Bio-absorbable Film – Acute  MI 
The bio-absorbable film acts as a protective layer and it restrict “slow flow – no flow” movement.

TECHNICAL SPECIFICATION

Drug | Polymer
Drug Sirolimus
Drug Dose 0.70 mcg/mm2
Drug Carrier Lactice and glycolide family of biodegradable polymer
Stent
Stent Material Cobalt Chromium Alloy L605
Strut Thickness 73 micron (0.0029”)
Strut Width 80 micron (hinge) – 120 micron (strut)
Average Recoil Less than 5%
Average Foreshortening Less than 1% (zero foreshortening design)
Delivery System
Delivery System Rapid exchange (Rx) stent delivery system
Nominal Pressure 8 bar
Rated Burst Pressure 14 bar

ABILITY RCT

The ABILITY RCT is designed to establish long term benefits of unique and innovative product design of Abluminus DES+ in Diabetic indication globally

OBJECTIVE

To compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus

DESIGN

Randomized, multi-centre, single-blinded controlled clinical trial to be conducted in Europe. A total of 165 patients with 110 in the Abluminus DES+ group and 55 in the Everolimus‐eluting DES group will be enrolled and evaluated. Patients will be followed-up for 12 months.

PRIMARY ENDPOINTS

In‐stent neointimal volume at 6‐month follow‐up, measured with OCT, following PCI with Abluminus DES+ compared with in‐stent neointimal volume following PCI with Everolimus eluting DES.

SECONDARY ENDPOINTS

Neointimal area, calculated at the site of minimal lumen area at 6-month follow-up measured with OCT.

Target Lesion Failure at 12 months

Stent thrombosis at 12 months

Cardiac death at 12 months

Target vessel myocardial infarction at 12 months

Target lesion revascularization at 12 months

Device success at 24 hours

Lesion success

Procedural success

  • Interventional cardiologist at San Raffaele Hospital and EMO-GVM Centro Cuore Columbus in Milan Italy.

     

    Ability - Envision Scientific - Advancing Innovation

    Principal Investigator

    Dr. Azeem Latib

  • Director, Cardiac Cath Lab and Interventional Cardiology Unit, EMO GVM Centro Cuore, Columbus and San Raffaele Hospital, Milan, Italy, Visiting Professor of Medicine, Columbia Medical Center

    Ability - Envision Scientific - Advancing Innovation

    Medical Director

    Dr. Antonio Colombo

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