R-One Efficiency For PCI Evolution With Robotic Assistance

NCT04163393 | Completed

• 1 other identifier: ROB-01
• Study Type: interventional
• Target: 62
• Locations: 4 countries
• Sites: 6

Brief Summary

This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: Number of patients with absence of Intra-procedural complications (Dissection, Thrombus, Air embolus, traumatic aorta)

  Absence of Intra-procedural complications (Dissection \>/= NHLBI type D, perforation, decrease of TIMI flow (\</= 2), acute occlusion, visible thrombus formation, significant air embolus, traumatic aortic or Left Main dissection by guiding catheter

  Peri-procedure

• Efficacy Endpoint: Number of Patients with Procedure technical success

  Procedure technical success defined as the successful advancement and retraction of all PCI devices (guidewires, balloon catheters and stents) and the successful treatment of all the target lesions using the R-One system and without conversion to manual operation

  During Procedure

Secondary Outcomes (7)

• Number of patients with Absence of each type of Intra-procedural complication (Dissection, Thrombus, Air embolus, traumatic aorta)

  During Procedure

• Procedure duration

  During Procedure

• Robot duration

  During Procedure

• Radiation exposure using dosimeters (Patient Radiation, Robot Dose, Procedure Dose)

  During Procedure

• Contrast Volume in mL

  During Procedure

Study Arms (1)

R-One

EXPERIMENTAL

Patients treated with robotic assistance

Procedure: Percutaneous Coronary Intervention; Device: Percutaneous Coronary Intervention using R-One assistance

Interventions

Percutaneous Coronary Intervention PROCEDURE

PCI with robotic assistance

R-One

Percutaneous Coronary Intervention using R-One assistance DEVICE

PCI with robotic assistance

R-One

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Candidate for PCI;
• Presence of a de novo coronary artery stenosis of ≥ 50% and \<100% in a native coronary artery indicated and suitable for stent implantation;
• The vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm;
• The target lesion length allows for treatment with a single stent up to 38 mm in length;
• Up to 2 target vessels each with a single target lesion requiring a single stent per lesion and treatable within a single procedure may be included (no further staged procedure allowed);
• The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.

You may not qualify if:

• Target lesion has TIMI flow \< 3;
• Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
• More than one target lesion per vessel requiring treatment at the time of procedure;
• Target lesion is a bifurcation requiring balloon or stent implantation of the side branch, with a side-branch RVD of ≥1.5 mm with a DS ≥50% at or within 5 mm its origin, or RVD ≥2.0 mm regardless of the presence of side branch disease;
• Target lesion is located in left main coronary artery, or any left main stenosis \> 30%;
• Target lesion is within 5 mm of the ostial LAD, ostial LCX or ostial RCA;
• Severe vessel tortuosity;
• Severe vessel calcification;
• STEMI, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of the procedure;
• Presence of visible thrombus;
• Need for any procedure other than balloon angioplasty or stenting (e.g. atherectomy, laser, are excluded);
• Patients under judicial protection, tutorship or curatorship (for France only);
• Any patient participating in another clinical study evaluating a drug or a medical device (except registries for which the primary endpoint has not been evaluated;
• Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.

Sponsors & Collaborators

• Robocath: lead

Study Sites (6)

Het Ziekenhuisnetwerk Antwerpen vzw

Antwerp, 2000, Belgium

Location

CHU Caen Normandie

Caen, 14033, France

Location

CHU Rouen

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

INCCI

Luxembourg, L-1210, Luxembourg

Location

Maastad Ziekenhuis

Rotterdam, 3079, Netherlands

Location

Related Publications (1)

• Durand E, Sabatier R, Smits PC, Verheye S, Pereira B, Fajadet J. Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study. EuroIntervention. 2023 Apr 3;18(16):e1339-e1347. doi: 10.4244/EIJ-D-22-00642.

  PMID: 36602883 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

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: October 15, 2019
• First Posted: November 14, 2019
• Study Start: September 17, 2019
• Primary Completion: November 8, 2021
• Study Completion: December 15, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (1); FR (3); LU (1)