Trial Outcomes & Findings for Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry (NCT NCT04034121)

Last Updated: 2021-07-14

Results Overview

Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2021-07-14

Participant Flow

Between 20 January 2016 and 18 July 2016 Nov 2017, 50 patients were enrolled in the study at 3 centers in Brazil (20 patients) and Belgium (30 patients)

Participant milestones

Participant milestones
Measure	DESolve Cx DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System The DESolve Cx Novolimus Eluting BCSS is comprised of four main components: the Poly-L-Lactic Acid-based polymer (PLLA) stent coated with a PLLA-based polymer-drug matrix containing the anti-proliferative drug Novolimus.
European Cohort STARTED	30
European Cohort COMPLETED	30
European Cohort NOT COMPLETED	0
Brazil Cohort STARTED	20
Brazil Cohort COMPLETED	20
Brazil Cohort NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DESolve Cx n=50 Participants DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System The DESolve Cx Novolimus Eluting BCSS is comprised of four main components: the Poly-L-Lactic Acid-based polymer (PLLA) stent coated with a PLLA-based polymer-drug matrix containing the anti-proliferative drug Novolimus.
Age, Continuous Age	60.0 years STANDARD_DEVIATION 10.3 • n=50 Participants
Sex: Female, Male Female	16 Participants n=50 Participants
Sex: Female, Male Male	34 Participants n=50 Participants
Region of Enrollment Belgium	30 participants n=50 Participants
Region of Enrollment Brazil	20 participants n=50 Participants
Cardiac Risk Factors Diabetes	10 Participants n=50 Participants
Cardiac Risk Factors Hypertension	35 Participants n=50 Participants
Cardiac Risk Factors Dyslipidemia	42 Participants n=50 Participants
Cardiac Risk Factors Family history of coronary artery disease	24 Participants n=50 Participants
Cardiac Risk Factors Smoking (previous or current)	35 Participants n=50 Participants
Cardiac Risk Factors Prior myocardial infarction	20 Participants n=50 Participants
Cardiac Risk Factors Prior percutaneous coronary intervention	13 Participants n=50 Participants
Baseline Lesion Characteristics Reference Vessel Diameter	3.03 mm STANDARD_DEVIATION 0.39 • n=50 Participants
Baseline Lesion Characteristics Minimum Lumen Diameter	1.17 mm STANDARD_DEVIATION 0.30 • n=50 Participants
Baseline Lesion Characteristics Lesion Length	16.16 mm STANDARD_DEVIATION 6.55 • n=50 Participants
Percent Diameter Stenosis	61.20 Percent STANDARD_DEVIATION 9.27 • n=50 Participants

PRIMARY outcome

Timeframe: 6 months

Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts

Outcome measures

Outcome measures
Measure	DESolve Cx n=50 Participants DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Clinically-indicated Major Adverse Cardiac Events	0 Participants

SECONDARY outcome

Timeframe: 6 months

quantitative QCA measurement of change in the lumen diameter from post procedure and 6 months which is described as "late lumen loss" This applies to both the European and Brazilian Cohorts

Outcome measures

Outcome measures
Measure	DESolve Cx n=50 Participants DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)	0.19 mm Standard Deviation 0.25

SECONDARY outcome

Timeframe: 12 months

Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to both the European and Brazilian Cohorts

Outcome measures

Outcome measures
Measure	DESolve Cx n=50 Participants DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Clinically-indicated Major Adverse Cardiac Events (MACE)	0 Participants

SECONDARY outcome

Timeframe: 24 months

Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This time point applies to the Brazilian Cohort only

Outcome measures

Outcome measures
Measure	DESolve Cx n=20 Participants DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Clinically-Indicated Major Adverse Cardiac Events	0 Participants

SECONDARY outcome

Timeframe: 36 months

Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the Brazilian Cohort only

Outcome measures

Outcome measures
Measure	DESolve Cx n=20 Participants DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Clinically-indicated Major Adverse Cardiac Events	0 Participants

Adverse Events

DESolve Cx

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DESolve Cx n=50 participants at risk DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Cardiac disorders non-clinically indicated target lesion revascularization	4.0% 2/50 • Number of events 2 • Major Adverse Event data was collected at 1 month, 6 months, 1, 2 and 3 years. MACE was defined as a composite endpoint of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization.

Other adverse events

Adverse event data not reported

Additional Information

Candace Elek, Executive Vice President, Clinical Research

Elixir Medical

Phone: 408-636-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place