Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
474

Summary

Conditions
  • Coronary (Artery) Disease
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Stenosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Single-blind, 1:1 Randomized trial of parallel designMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 125 years
Gender
Both males and females

Description

The Bioadaptor RCT Study is a prospective, 2:1 randomized study of parallel designed, that will enroll up to 474 patients requiring treatment of up to two de novo coronary lesions of ? 24 mm in length in vessels of ? 2.5 mm and ? 3.5 mm in diameter. One or two designated target lesions, located in s...

The Bioadaptor RCT Study is a prospective, 2:1 randomized study of parallel designed, that will enroll up to 474 patients requiring treatment of up to two de novo coronary lesions of ? 24 mm in length in vessels of ? 2.5 mm and ? 3.5 mm in diameter. One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or LAD), and meeting the inclusion/exclusion criteria may be treated with the ELX1805J (DynamX Bioadaptor) or Resolute Onyx stent The primary safety endpoint is Target Lesion Failure (TLF) at 12 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and 12 months and 2-5 years. Using visual assessment, the target lesion must measure ? 2.5 mm and ? 3.5 mm in diameter and ? 24 mm in length able to be covered by a single ELX1805J or Resolute Onyx stent including 2 mm of healthy vessel on either side of the planned treatment area. The patient will be eligible for device implantation only after satisfactory lesion pre-dilatation defined as: ? TIMI 2 flow, and no dissection greater than Grade B (NHLBI) able to be covered with a single device

Tracking Information

NCT #
NCT04192747
Collaborators
Not Provided
Investigators
Principal Investigator: Shigeru Saito, MD Chief Director, Shonan Kamakura General Hospital