Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry

• Sponsor: Elixir Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04034121
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arm: 1
• Actual Duration (Months): 56.3
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: DESolve Cx drug eluting coronary scaffold system	N/A

Detailed Description

The DESolve Cx Single-Arm Registry enrolled patients using the same inclusion and exclusion criteria and clinical endpoints as the DESolve Nx Study

This study was split into 2 cohorts - European and Brazilian. The European cohort (30 subjects) completed all follow-up at 1 year and the Brazilian cohort at 3 years (20 subjects)

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single armsingle arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Non-randomized Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System in de Novo Native Coronary Artery Lesions - DESolve Cx Single-Arm Registry
• Actual Study Start Date: Jan 20, 2016
• Actual Primary Completion Date: Jan 22, 2017
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: DESolve Cx DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System	Device: DESolve Cx drug eluting coronary scaffold system; percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

1. Clinically-indicated Major Adverse Cardiac Events [6 months]

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

Secondary Outcome Measures

1. In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA) [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

2. Clinically-indicated Major Adverse Cardiac Events (MACE) [12 months]

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

3. Clinically-Indicated Major Adverse Cardiac Events [24 months]

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

4. Clinically-indicated Major Adverse Cardiac Events [36 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient must be at least 18 years of age and for the 35-patient subset, patients must be over the age of 50

• Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure

• Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)

• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

• Patient must agree to undergo all clinical study required follow-up visits, angiograms, and as applicable, imaging testing

• Patient must agree not to participate in any other clinical study for a period of two years following the index procedure

• Target lesion must be located in a native coronary artery with a nominal vessel

• Not part of a clinical investigation

• Treatment of a single, non-target lesion located in a separate major epicardial vessel Target vessel diameter must be a diameter of between 2.25 and 3.5 mm assessed by online QCA

• Target lesion must measure ≤ 24 mm in length

• Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 1

• Target vessel must be in a major coronary artery or major branch

Exclusion Criteria:

• Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and cardiac enzymes have not returned within normal limits at the time of procedure

• Patient is currently experiencing clinical symptoms consistent with AMI

• Patient requires the use of any rotablator intervention during the index procedure

• Patient has current unstable arrhythmias

• Patient has a known left ventricular ejection fraction (LVEF) < 30%

• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant

• Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure

• Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)

• Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.

• Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated

• Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel

• Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease.

• Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)

• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

• Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

• Patient has had a significant GI or urinary bleed within the past six months

• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion

• Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)

• Patient is already participating in another clinical study

• Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing

• Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority

• Target lesion(s) meets any of the following criteria:

• Aorto-ostial location

• Left main location

• Located within 5 mm of the origin of the LAD or LCX

• Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft

• Lesion involving a side branch >2mm in diameter or bifurcation

• Previous placement of a scaffold proximal to or within 10 mm of the target lesion

• Total occlusion (TIMI flow 0), or TIMI flow < 1

• Excessive tortuosity proximal to or within the lesion

• Angulation (≥ 45o) proximal to or within the lesion

• Calcification moderate or heavy

• Previous intervention restenosis

• The target vessel contains visible thrombus

• Another clinically significant lesion (>40%) is located in the same major epicardial vessel as the target lesion

• Patient has a high probability that a procedure other than pre-dilatation and scaffolding and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Middelheim Hospital	Antwerp		Belgium	2020
2	St. - Jan Ziekenhuis Z.O.L.	Genk		Belgium	B-3600
3	Instituto Dante Pazzanese	Sao Paulo		Brazil	0401210

Sponsors and Collaborators

• Elixir Medical Corporation

Investigators

• Principal Investigator: Stefan Verheye, MD, ZNA Antwerp Belgium

Study Documents (Full-Text)

• Study Protocol: European Cohort - Oct 4, 2017
• Study Protocol: Brazil Cohort - Feb 5, 2018
• Informed Consent Form: European Cohort - Oct 23, 2015

More Information

Publications

None provided.

• Responsible Party: Elixir Medical Corporation
• ClinicalTrials.gov Identifier: NCT04034121
• Other Study ID Numbers: ELX-CL-1003 Cx
• First Posted: Jul 26, 2019
• Last Update Posted: Jul 14, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Elixir Medical Corporation: biorersorbable scaffold; drug eluting; novolimus
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	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)

Arm/Group Title	DESolve Cx
Arm/Group Description	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.
Period Title: European Cohort
STARTED	30
COMPLETED	30
NOT COMPLETED	0
Period Title: European Cohort
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	DESolve Cx
Arm/Group Description	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.
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Age	60.0 (10.3)
Sex: Female, Male (Count of Participants)
Female	16 32%
Male	34 68%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Belgium	30 60%
Brazil	20 40%
Cardiac Risk Factors (Count of Participants)
Diabetes	10 20%
Hypertension	35 70%
Dyslipidemia	42 84%
Family history of coronary artery disease	24 48%
Smoking (previous or current)	35 70%
Prior myocardial infarction	20 40%
Prior percutaneous coronary intervention	13 26%
Baseline Lesion Characteristics (mm) [Mean (Standard Deviation) ]
Reference Vessel Diameter	3.03 (0.39)
Minimum Lumen Diameter	1.17 (0.30)
Lesion Length	16.16 (6.55)
Percent Diameter Stenosis (Percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent]	61.20 (9.27)

Outcome Measures

1. Primary Outcome

Title	Clinically-indicated Major Adverse Cardiac Events
Description	Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the European and Brazilian Cohorts
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DESolve Cx
Arm/Group Description	DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Measure Participants	50
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	In-scaffold Late Lumen Loss by Quantitative Coronary Angiography (QCA)
Description	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
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DESolve Cx
Arm/Group Description	DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Measure Participants	50
Mean (Standard Deviation) [mm]	0.19 (0.25)

3. Secondary Outcome

Title	Clinically-indicated Major Adverse Cardiac Events (MACE)
Description	Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to both the European and Brazilian Cohorts
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DESolve Cx
Arm/Group Description	DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
Measure Participants	50
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Clinically-Indicated Major Adverse Cardiac Events
Description	Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This time point applies to the Brazilian Cohort only
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DESolve Cx
Arm/Group Description	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.
Measure Participants	20
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Clinically-indicated Major Adverse Cardiac Events
Description	Number of Participants with one or more Clinically-indicated Major Adverse Cardiac Events This applies to the Brazilian Cohort only
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DESolve Cx
Arm/Group Description	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.
Measure Participants	20
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	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.
Arm/Group Title	DESolve Cx
Arm/Group Description	DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System DESolve Cx drug eluting coronary scaffold system: percutaneous coronary intervention
All Cause Mortality
	DESolve Cx
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	DESolve Cx
	Affected / at Risk (%)	# Events
Total	2/50 (4%)
Cardiac disorders
non-clinically indicated target lesion revascularization	2/50 (4%)	2
Other (Not Including Serious) Adverse Events
	DESolve Cx
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.