A Phase I/II Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Subjects With Chronic Refractory Myocardial Ischemia

Helixmith Co., Ltd.2 sites in 1 countryMarch 1, 2015

ConditionsMyocardial Ischemia

InterventionsVM202

DrugsVM202

Overview

Phase: Phase 1
Intervention: VM202
Conditions: Myocardial Ischemia
Sponsor: Helixmith Co., Ltd.
Locations: 2
Primary Endpoint: The primary study objective is to evaluate safety and tolerability of a catheter-based, endocardial injection of different doses of VM202.
Status: Withdrawn
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of catheter based injections of VM202 into the heart.

Detailed Description

A phase I/II, open label, dose-escalation, multicenter, 12 month study designed to assess the safety and tolerability of catheter based percutaneous myocardial injection of VM202 in patients with chronic refractory myocardial ischemia. The study will consist of three (3) cohorts with a total of 4 subjects enrolled in each cohort. Endocardial injections will be performed with the MyoStar Injection Catheter under guidance of the NOGA XP Cardiac Navigation System.

Registry

clinicaltrials.gov

Start Date

March 1, 2015

End Date

January 1, 2016

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Helixmith Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 21 years, but less than or equal to 75 years.
•Stable chronic refractory angina classified as Canadian Cardiovascular Society (CCS) functional class II - IV
•Left ventricular ejection fraction (LVEF) of ≥30% and ≤ 50%;
•Clinical signs and symptoms of significant ischemia by treadmill test or Stress imaging (SPECT, Echo or CARDIAC MRI acceptable)
•Subjects must be able to complete a minimum of 3 minutes, but no more than 10 minutes on a Modified Bruce treadmill protocol.
•Patients on maximal medical therapy including at least 2 of the following (unless hemodynamic parameters or intolerance contraindicate their use):(a) Long acting nitrate, (b) Beta Blocker or (c) Calcium Channel Blocker (d) Ranolazine. Optimal medical regimen for each subject will be decided by the referring cardiologist or principal investigator. Patients must be on stable medical regimen for 30 days prior to enrollment.
•Coronary angiogram within 1 year to confirm the presence of coronary disease which is not amenable to standard revascularization procedures.
•Candidates must not be eligible for any other revascularization procedures. The participant and his/her coronary film must have been discussed with an independent cardiac surgeon and must have been denied for CABG or PTCA. Participants who are marginal or poor candidates for conventional revascularization will be considered eligible if the risks of performing a CABG or PTCA procedure outweigh the potential benefit and/or such a procedure is unlikely to offer a worthwhile clinical benefit. The criteria defining such cases may include, but may not be limited to, the following examples:
•Diffuse or distal vessel disease
•Chronic occlusions

Exclusion Criteria

•Subjects who have undergone a successful revascularization procedure within 6 months of enrollment;
•MI, unstable angina requiring \> 24 hour hospitalization, or percutaneous coronary intervention, within last 90 days;
•Stroke or TIA within last 180 days;
•Predominant CHF symptoms;
•Hemodynamically significant severe primary valvular heart disease, unless corrected by a properly functional prosthetic valve;
•Uncontrolled hypertension as defined as systolic BP 170 mmHg or diastolic \> 90 mmHg at baseline/ screening evaluation;
•Sustained ventricular tachycardia or automatic implantable cardiodefibrillator (AICD) firing within last 180 days;
•History of ventricular fibrillation;
•Use of the MyoStar catheter may not be appropriate for patients with prosthetic valves. Patients with a mechanical valve at risk for injury due to the interventional approach should be excluded;
•Subjects with any comorbidity that may interfere with the ability to perform a maximal treadmill test (e.g. severe arthritis, musculoskeletal disorders, COPD);

Arms & Interventions

Cohort 1

Eight endocardial injection for a total dose of 1mg VM202

Intervention: VM202

Cohort 2

Eight endocardial injections for a total dose of 2mg VM202

Intervention: VM202

Cohort 3

Twelve endocardial injections for a total dose of 3mg VM202

Intervention: VM202

Outcomes

Primary Outcomes

The primary study objective is to evaluate safety and tolerability of a catheter-based, endocardial injection of different doses of VM202.

Time Frame: Days 1, 7, 14, 21, 30, 60, and 90, 6 and 12 months

Secondary Outcomes

Efficacy measures include exercise treadmill test, SPECT, cardiac MRI and change in use of anti-anginal medications.(Days 1, 7, 14, 21, 30, 60, and 90. 6 and 12 months)
Secondary objectives include the assessment of the angiogenic potential of VM202(one month, three months, six months and twelve months)