Total Occlusion Study in Coronary Arteries - 5 (TOSCA-5)

Matrizyme Pharma

Status and phase

Completed

Phase 2

Conditions

Chronic Coronary Total Occlusions

Treatments

Drug: saline

Biological: collagenase

Study type

Interventional

Funder types

Industry

Identifiers

NCT01753180

CTO-201

Details and patient eligibility

About

A prospective, multi-center, double blind, 2 stage, placebo-controlled, phase II study, evaluating acute intra-coronary injected collagenase prior to routine standard-of-care percutaneous revascularization procedures in subjects with chronic total coronary artery occlusions (CTOs).

Enrollment

76 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or females patients > 18 years of age who has a clinically driven, planned PCI of the target CTO, in a major epicardial coronary artery, without planned revascularization of other coronary stenosis/stenoses in major epicardial segments.
Target CTO must be greater than or equal to 3 calendar months prior to Screening
Target CTO must meet protocol defined criteria for entry
Patient is receiving a course of optimal anti-ischemic medical therapy (at least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy)

Exclusion criteria

Documented chest radiation exposure > 4.0 Gray within 8 weeks of Day 0
Target vessel is not an occluded stent, saphenous vein graft
Patient had ACS < 4 weeks from Screening, attributable to any coronary vessel
Patient has non-healed dissection plane extending to a point adjacent to the coronary lumen distal to the target CTO
Patient has a known or suspected target vessel perforation within 30 days of Day 0
Angiographic exclusion criteria as defined in the protocol