ot applicable

Phase 1

• Conditions: Patients with clinical evidence of severe claudication or chronic critical limb ischemia with an angiographically significant lesion in the infrapopliteal crural vessels.; MedDRA version: 20.0Level: PTClassification code 10057525Term: Peripheral artery occlusionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0Level: PTClassification code 10072563Term: Peripheral artery stenosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.1Level: PTClassification code 10057518Term: Peripheral artery angioplastySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002071-13-AT
• Lead Sponsor: Mercator MedSystems, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-08
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Screening Criteria
oAge =18 years and <90 years
oPatient has been informed of the nature of the study, agrees to participate and has signed an IRB/EC approved consent form
oFemale patients of childbearing potential have a negative pregnancy test =7 days before the procedure and are willing to use a highly effective method of birth control (see Section 12.2) for one month preceding and24 months following study treatment
oPatient has documented severe claudication or chronic Critical Limb Ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 3, 4, 5 or 6
oLife expectancy >1 year in the Investigator's opinion

•Angiographic Criteria
oTarget vessel(s) diameter =2 mm and =8 mm
oSingle or multiple atherosclerotic lesion(s) =70% in at least one infrapopliteal crural target vessel including the tibioperoneal trunk that totals up to no greater than 30 cm in length (with no greater than 5 cm length of contiguous intervening normal artery), with possible extension into the popliteal artery distal to the center of the knee joint space (the P3 segment)
oSuccessful revascularization of the TL with less than 30% residual stenosis, run-off down to the foot and direct in-line flow to any foot wound, if a wound is present at baseline

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Screening Criteria
1. Patient unwilling or unlikely to comply with visit schedule
2. Planned major index limb amputation
3. Active foot infection; however, osteomyelitis in the toes or mild cellulitis around the perimeter of gangrene or small ulcers are not exclusions, but osteomyelitis of the metatarsal or more proximal region would be exclusionary
4. Inability to receive study medications
5. Estimated glomerular filtration rate (eGFR) less than 30 mL/min, except for patients with end stage renal disease on chronic hemodialysis
6. Stage 3 (per SVS WIfI classification) or worse heel ulcers or heel ulcers that are determined to be primarily neuropathic in nature

Angiographic/Procedural Criteria
1. Hemodynamically significant inflow lesion (=50% DS) or occlusion in the ipsilateral iliac, SFA, or popliteal arteries in which there is a failure to successfully treat and obtain a <30% residual stenosis
2. Index lesion length is >30 cm as measured from proximal normal vessel to distal normal vessel
3. Total length of lesions treated during the case (including target lesion, inflow lesions, and other non-index lesions) >50 cm
4. Lesions revascularized during the index case but untreated by Bullfrog
5. Use of alternative therapy, e.g. atherectomy, laser, or radiation therapy, as part of the index lesion treatment, or use of any drug eluting stents (DES) or drug-eluting balloon/drug-coated balloons (DEB/DCB) for treatment of any infra-inguinal lesions during the study procedure or during the initial six-month follow up period
6. Previously implanted stent in the TL(s)
7. Aneurysm in the target vessel
8. Acute thrombus in the target limb
9. Failure to cross the TL with a guide wire; however, subintimal wire crossing is allowed
10. Heavy eccentric or concentric calcification at index lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified