CompletedNot Applicable

Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial

Belgium, New Zealand16 participantsStarted 2011-02

Plain-language summary

This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions \< 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus. * Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months. * Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months. * Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient must be at least 18 years of age * Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Myolimus Eluting BCSS and he/she or his/her legally authorized representative 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 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, IVUS, OCT and MSCT * Patient must agree not to participate in any other clinical study for a period of two years following the index procedure Exclusion Criteria: * Patients has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure * The patient is currently experiencing clinical symptoms consistent with AMI * Patient has current unstable arrhythmias Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or tar…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

Timeframe: 1 month

Clinically-Indicated Target Lesion Failure (CI-TLF)

Timeframe: 1 month

Clinically-Indicated Target Vessel Failure (CI-TVF)

Timeframe: 1 month

Clinically-Indicated Target Vessel Revascularization (CI-TVR)

Timeframe: 1 month

Stent thrombosis

Timeframe: 1 month

Acute success - Procedure success

Timeframe: 7 days

Acute success - Device success

Timeframe: 7 days

Stent thrombosis

Timeframe: 6 months

Trial details

NCT IDNCT02086006

SponsorElixir Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

Timeframe: 1 month

Clinically-Indicated Target Lesion Failure (CI-TLF)

Timeframe: 1 month

Clinically-Indicated Target Vessel Failure (CI-TVF)

Timeframe: 1 month

Clinically-Indicated Target Vessel Revascularization (CI-TVR)

Timeframe: 1 month

Stent thrombosis

Timeframe: 1 month

Acute success - Procedure success

Timeframe: 7 days

Acute success - Device success

Timeframe: 7 days

Stent thrombosis

Timeframe: 6 months