NCT01845311

Brief Summary

The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

March 21, 2013

Last Update Submit

March 27, 2023

Conditions

Coronary Artery DiseaseCoronary Artery Stenosis

Outcome Measures

Primary Outcomes (3)

  • Major Adverse Cardiac Events (MACE)

    6 Months

  • Major Adverse Cardiac Events

    12 Months

  • Late Lumen Loss

    9 Months

Secondary Outcomes (8)

  • QCA derived parameters

    9 Months

  • Major Adverse Coronary Events

    24, 36, 48 & 60 Months

  • TLR

    12,24,36,48 & 60 Months

  • TVR

    12,24,36,48 & 60 Months

  • TVF

    12, 24, 36, 48 & 60 Month

  • +3 more secondary outcomes

Study Arms (1)

ReZolve2 Treatment Group

EXPERIMENTAL
Device: ReZolve2 Scaffold

Interventions

ReZolve2 ScaffoldDEVICE
ReZolve2 Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has evidence of myocardial ischemia or a positive functional study
  • Patient has a normal CK-MB
  • Target lesion has a visually estimated stenosis of ≥50% and \<100%
  • Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm
  • Target lesion length must be ≤ 14mm

You may not qualify if:

  • Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure
  • Patient has a left ventricular ejection fraction \< 30%
  • Patient has unprotected lest main coronary disease with ≥50% stenosis
  • The target vessel is totally occluded (TIMI Flow 0 or 1)
  • Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
  • Target lesion is located within a bypass graft
  • Target lesion has possible or definite thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St Vincent's Hospital

Sydney, Australia

Location

Instituto Dante Pazzanese de Cariologia

São Paulo, Brazil

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Alexandre Abizaid, MD

    Instituto Dante Pazzanese de Cardiologia

    PRINCIPAL INVESTIGATOR

  • David Muller, MD

    St Vincent's Hospital, Sydney

    PRINCIPAL INVESTIGATOR

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

March 21, 2013

First Posted

May 3, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2019

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

DE(1)AU(1)BR(1)