Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery (MCA) M1 segment

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: Kallikreins

Criteria

Inclusion Criteria:

1. TIA or stroke in the MCA territory refractory to aggressive anti-platelet and regular statin therapy in 3 months

2. Symptomatic MCA M1 segment stenosis ≥ 70% confirmed with DSA

3. Successfully treated with PTAS without acute surgical complications in 12 hours after operation

4. All patients provided fully informed consent

Exclusion Criteria:

1. Using angiotensin-converting enzyme inhibitors

2. Severe cardiopulmonary dysfunction, chronic liver disease (A / G inversion, ALT increased 2-fold greater than normal), abnormal renal function (serum creatinine greater than 1.5 times normal)

3. Allergies, the history of allergy to multi-drug

4. The history of cerebral hemorrhage, brain tumors, brain trauma, cerebral embolism and other brain lesions

5. During pregnancy or breast-feeding

6. Not expected to complete follow-up