LIFE-BTK PK Sub-study

Status Active, not recruiting

Clinical Trial Summary

LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Of the 7 subjects planned to be enrolled, 4 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom drug-coated balloons (DCB) were not used; 3 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom DCB were used for treatment of inflow disease.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Chronic Limb-Threatening Ischemia
Critical Limb Ischemia (CLI)
Ischemia

Clinical Trial Details

NCT number	NCT05208905
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 10, 2022
Completion date	February 22, 2028

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02287974` - Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin	Phase 1/Phase 2
Active, not recruiting	`NCT03006770` - Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization	Phase 3
Completed	`NCT00987363` - Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization	Phase 1/Phase 2
Not yet recruiting	`NCT02538978` - Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System	Phase 3
Completed	`NCT01408381` - Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).	Phase 2
Recruiting	`NCT04849325` - IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease	N/A
Completed	`NCT01257776` - Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients	Phase 1/Phase 2
Active, not recruiting	`NCT04227899` - LIFE-BTK Randomized Controlled Trial	N/A
Terminated	`NCT03111238` - The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM	Phase 3
Terminated	`NCT03174522` - The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM	Phase 3
Completed	`NCT01386216` - Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)	Phase 1
Available	`NCT03746899` - Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
Available	`NCT03886506` - Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization