ARTDIVA Study : First in Man Safety Evaluation of the ART18Z Bioresorbable Stent

NCT01761578 | Completed DMC

• 1 other identifier: ARTDIVA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

This prospective, multicentre, open labeled, single arm, first in man interventional investigation aims to evaluate the safety of the ART18Z bioresorbable stent for the treatment of patients with single de novo lesion of a native coronary artery with mandatory balloon predilatation.

Conditions

Coronary Artery Disease

Keywords

Bioresorbable; Coronary; Stent; Vascular Remodeling; Angioplasty; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• MACE rate

  Major Adverse Cardiac Event is defined as death, MI (Myocardial Infarction) or any TLR (Target Lesion Revascularization).

  at 6 months

Secondary Outcomes (7)

• Acute Performances (Device/Procedure Success)

  Procedure and post-procedure up to 24 hours

• Stent thrombosis

  at 1, 3, 6, 12, 18 months

• Clinically driven TVF, TLR, TVR

  at 1, 3, 6, 12, 18 months

• Evolution of Angiographic binary restenosis

  at 12 months

• Evolution of Angiographic in-stent Late Lumen Loss

  at 12 months

Study Arms (1)

ART18Z Bioresorbable stent

EXPERIMENTAL

Device: ART18Z Bioresorbable stent

Interventions

ART18Z Bioresorbable stent DEVICE

The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.

ART18Z Bioresorbable stent

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Target lesion must meet all of the following criteria
• Single vessel lesion
• De novo lesion
• Located in a native coronary artery with visually estimated nominal artery diameter of 2.8 to 3.2 mm
• Length ≤ 8 mm visually estimated
• Located in a major artery or branch with a visually estimated stenosis \>50% and \<100% with a TIMI flow ≥1
• Patient profile:
• Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ART18Z Bioresorbable Stent.
• Patient provides written informed consent approved by the EC prior to any clinical investigation related procedure
• Patient must agree to undergo all clinical investigation plan - required clinical follow-up visits, QCA, OCT
• Patient must agree not to participate in any other clinical investigation for a period of 3 years following the procedure
• a social security number is required, otherwise patients cannot be included in the trial.
• Clinical profile:
• Silent ischemia, stable or unstable angina with documented ischemia (stress echocardiography, 12-lead ECG, nuclear imaging, bicycle test, Treadmill stress test)
• months limited clopidogrel treatment must be acceptable in compliance with patient health status

You may not qualify if:

• Target lesion meets any of the following criteria:
• Aorto-ostial location (within 3 mm)
• Left main location
• located within 3 mm of the origin of the LAD or LCX
• Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \>20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
• Lesion involving a bifurcation ≥ 1.5 mm in diameter and ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation
• Excessive tortuosity proximal to or within the lesion (Extreme angulation (≥ 90%) proximal)
• Calcification lesion
• Restenotic from previous intervention
• The target vessel contains visible thrombus
• Chronic total occlusion (CTO)
• Another clinically significant lesion is located in the same major epicardial vessel as the target lesion (including side branches)
• Patient has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)
• Non clinical investigation percutaneous intervention in the target vessel \< 6 months prior to or if planned to be done within 6 months after the investigational procedure.
• Non clinical investigation percutaneous intervention in a non-target vessel \< 1 months prior to the investigational procedure with TIMI flow = 3 and no evidence of dissection at the time of the clinical investigation procedure, or if planned to be done within 6 months after the investigational procedure.

Sponsors & Collaborators

• Arterial Remodeling Technologies: lead

Study Sites (5)

Polyclinique les Fleurs

Ollioules, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Haut Leveque

Pessac, France

Location

Clinique Pasteur

Toulouse, France

Location

Hôpital Rangueil

Toulouse, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Vascular Remodeling

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 7, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

FR (5)