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Clinical Trials
   
PANDA I (BuMA™ vs. Endeavor™)
Time frame: 2008-2010
Principal Investigator: Dr. Shu-zheng Lv, Beijing Anzhen Hospital, China
Status: Completed

 Prospective parallel controlled multicenter study

 224 patients (113 cases for BuMA™ and 111 cases for Endeavor) in China with de novo coronary artery lesions, stenosis > 70%, target lesion length <40mm and target artery diameter between 2.0mm to 4.0mm.

 Primary endpoints: the measurement of late loss with quantitative coronary angiography (QCA) 270 (+30) days after stent implantation. 

 Secondary endpoints: major cardiac events (MACE) up to 720 days and implantation success rate.

Study outcomes

Conclusion

From the QCA results of 720 days, it is shown that late loss of BuMA™ is significant lower that the control group. This demonstrates the effective reduction of restenosis of the BuMA™. Our secondary endpoint has also shown superior patient outcomes in MACE comparing to Endeavor. After 720 days, the difference of 3.72% is shown superior for BuMA™. The great difference is found in the QCA result between 240 and 360 days. For Endeavor, the MACE events increases with the number of days. However, MACE events of BuMA™ patients are only discovered during QCA where patient themselves do not have physical complaints. After QCA, no additional MACE events are discovered till 720 days. With these outcomes, BuMA™ is considered to be a drug-eluting stent with outstanding clinical effectiveness that result in long-term patient safety.

PANDA I OCT-subset
Time frame: 2008-2010
Principal Investigator: Dr. Yun-dai CHEN, The General Hospital of the People's Liberation Army, China
Status: Completed

 To evaluated neointimal proliferation after placement of BuMA™ and Endeavor™ by using OCT analysis.

 From the total patients of PANDA I, patients for both BuMA™ (N = 22) and Endeavor™ (N = 7) group underwent OCT imaging after 9 months of stent implantation.

Study outcomes

The neointima hyperplasia (NIH) thickness in BUMA group were significantly smaller than that in endeavor group (0.220-/+0.140 mm vs 0.269-/+0.207 mm, P<0.001), and the uncovered Struts were significantly lower in BUMA group than in Endeavor group (5.65% vs 6.56%, P<0.0001). The luminal late loss in BUMA group was also significantly lower (34.87-/+11.50 vs 40.82-/+18.53, P=0.025).

Conclusion

BuMA™ is safe and effective for treatment of coronary artery disease. It is also superior when observing the results comparing the results of Endeavor.

PANDA II (BuMA™ Registry)
Time frame: 2011-2016
Principal Investigator: Dr. Yong HUO, Peking University 1st Hospital, China
Status: Enrollment completed, 1st year result in Q4 2014 

 Registry multicenter study

 2500 patients in China

 To observe long-term safety of BuMA™ in real world situation,

 Primary endpoint: major cardiac events (MACE) after 1 year stent implantation.

 Secondary endpoint: MACE events occurred in 5 years and late lumen loss till 2 years after stent implantation. 

PANDA III (BuMA™ vs. EXCEL™)
Time frame: 2013-2018
Principal Investigator: Dr. Run-lin GAO, Fu Wai Hospital, China
Status: Enrolling

 Prospective multicenter RCT comparing BuMA™ with EXCEL (BIOMATRIX licensed brand to JW Medical)

 Evaluating non-inferiority of two biodegradable drug-eluting stents in China.

 2350 patients enroling in 50 centers.

 Primary endpoint: target lesion failure (TLF) after 1 year stent implantation

 Secondary endpoint: target vessel failure (TVF), major adverse events (MACE), target lesion revascularization  (TLR) with follow-up of 1 month, 6 months and  1 to 5 years

PANDA III OCT-Subset
Time frame: 2013
Principal Investigator: Dr. Bo XU, Fu Wai Hospital, China
Status: Completed

 The objective of this three month OCT study if to have a comparative evaluation of BuMA™ and EXCEL (Domestic brand of BIOMATRIX)  in terms of the extent of neointima formation after 3 months stent implantation using OCT.

 Prospective, single center, randomized, open-label and non-inferiority study enrolls totally 70 patients in Fuwai hospital in Beijing, China. All patients are randomly assigned undergoing implantation of either BuMA™ or EXCEL (in a 1:1 ratio). If non-inferiority is met, a superiority test will be performed.

Study outcomes

 

Conclusion

BuMA-OCT is the first randomized trial to compare early neointimal coverage between two differently designed biodegradable polymer DES. The primary endpoint, the proportion of covered struts was higher with BuMA™ compared to EXCEL. Large-scale trial is warranted to further confirm the real clinical difference.

OCT Study (BuMA™ vs. XIENCE V™)
Time frame: 2012-2013
Principal Investigator: Dr. Bo Yu, 2nd Affiliated Hospital of Harbin Medical University, China
Status: Completed

 To observe any difference in two kind of stent by using OCT method. It is questioned whether BuMA™ could achieve better endothelial coverage compared to XIENCE V.

 Design: to implant  BuMA™ and XIENCE V overlapped in the same lesion, same vessel of the same patient to optimally reduce blood vessel variances.

 20 patients between 18 – 75 years old who require PCI treatment with stable angina or acute coronary syndrome (ACS) are enrolled in this study evenly divided in each group. Angiography and OCT will be taken before and 3, 6 and 12 months after implantation.

 The primary endpoint is endothelial coverage at 3 months. Secondary endpoint include endothelial coverage at 12 months, clinical events and clinical follow-up up to 3 years.

Study outcomes

Conclusion

 Evaluated by OCT, the neointimal coverage on struts were similar between BuMA™ and XIENCE V at 3 months after the implantation. A near complete endothelial coverage is achieved in both groups (95.0% vs. 94.7%, BuMA™ vs. XIENCE V, P=0.653).

 The BuMA™ has a significantly better endothelial coverage than the XIENCE V at 12 months (99.2% vs. 98.2%, BuMA™ vs. XIENCE V, P<0.001).

 BuMA™ has thicker neointimal hyperplasia thickness (0.15±0.10mm vs. 0.12±0.56mm, BuMA™ vs. XIENCE V, P<0.001) and larger neointimal area (1.44±1.04mm2 vs.1.05±0.49mm2, BuMA™ vs. XIENCE V, P<0.001), compared with XIENCE V at 12 months follow up. The clinical efficacy comparison between the both stents needs to be evaluated in large scale clinical trials.

PIONEER Trial in Europe
BuMA Supreme™ Europe First-in-man Trial  (BuMA Supreme™ vs. Resolute Integrity™)
Time frame:  First patient in- Apr. 2015, last patient in- Nov. 2015
Chairman: Prof. Patrick Serruys, the Netherlands
Principal Investigators: Prof. Manel Sabaté, Clinic University Hospital, Barcelona, Spain; Prof. Clemens von     Birgelen, Medisch Spectrum Twente (MST), Enschede, the Netherlands
Status: Enrollment ongoing

  Prospective multicenter RCT comparing BuMA Supreme with Resolute Integrity in patients with de novo coronary artery lesions.

  168 patients enrolling in 13 centers in 4 countries (the Netherlands, Spain, Belgium and Portugal).

  Primary endpoint: The measurement of In-stent late lumen loss with quantitative coronary angiography (QCA) 9 month after stent implantation.

  Secondary endpoints: Angiographic endpoints (Acute lumen gain, in-segment LLL, MLD , diameter       stenosis at 9 month, binary restenosis at 9 month), Clinical endpoints (Acute success, device oriented endpoints, death, MI, revascularization, stent thrombosis)