Clinical Studies

Qualimed development has been founded on a sound clinical evaluation strategy that has produced a number of published studies that are available for your prevue. Please find below a list of our Cardiology, Peripheral Vascular Studies.

Cardiology
No.

1

Device/Study

Stainless Steel Stent SC-Registry

Report/Publication

Voigt et al 2000 (Kardiologie-Abstract) - Der Stainless Steel-Stent - Erste Erfahrungen und Ergebnisse

Patients

70

Outcome

6mFU RR 17.1%

Result

Stainless Steel Stent is safe with a low restenosis rate after 6 months

2

Stainless Steel Carbon PREVENT Study MC-RCT

Sick et al 2004 (DGK-Abstract) - Prospektiv randomisierte Vergleichsstudie PREVENT

396

6mFU, RR 18.0%, MACE 13.5%

Safe and effective compared to stainless steel stent

3

Cobalt Chromium Stent PASS Study MC-RCT

Park et al 2002 (Am J Cardiol-Abs) - Randomized Comparison Cobalt Chromium Stent - PASS-Study

230

21mFU, RR 11%

Cobalt Chromium Stent reduces the restenosis rate (11% vs 18%)

4

Cobalt Chromium Stent Study SC-Registry

Schukro et al 2003 (Int Con CAD) - Preliminary Results of ArthosInert Registry

121

8mFU, RR 8.2%, MACE 8.2%

Good clinical results and low restenosis rate

5

Cobalt Chromium Stent IRIS Trial MC-RCT

Fourrier J et al 2012 (Interim Report) - IRIS - Bioactive Carbonized Stent Trial

155

6mFU, MACE 11.5%, TLR 4.5%, RR 4.5%

This stent has shown an unexpected safety and efficacy outcome in all-comer population

6

Cobalt Chromium Stent AUSTRIAN Study MC-Registry

Gyöngyösi et al 2004 (CV News) - Results of Cobalt Chromium Stent Austrian Multicenter Registry

199

6mFU, LLL 0.42mm, MACE 13.2%

Stenting of small vessel with Cobalt Chromium Stent is safe. Good results with excelent late lumen loss

7

Cobalt Chromium Stent PIPA Study MC-Registry

Garcia E 2004 (Presentation) - PIPA Results

512

6mFU, MACE 5.4%

Very good short and midterm results in the treatment of lesions in small vessels

8

Cobalt Chromium Stent PIVER Study SC-Registry

Lefebvre et al 2004 (Cardiology) - Primary Results of PIVER (CoCr Small Vessel Registry)

71

1mFU, MACE 8.6%

PIVER indicate a very high success level in the difficult treatment of small vessels

9

Paclitaxel Drug Eluting Stent APPLAUSE Study SC-RCT

Grube et al 2006 (J Inv Card) - Evaluation of a new Paclitaxel-Eluting Stent - APPLAUSE Trial

30

6mFU, MACE 10.5% vs 40%

Early evidence in safety and efficacy of Paclitaxel Drug Eluting Stent at 6 months follow up

10

Paclitaxel Drug Eluting Stent ELITE Study MC-Registry

Glogar 2010 (Cardiology Int) - ELITE Registry Europe - non randomized multi-centre study

377

2yFU, TVR 7.8%

Paclitaxel Drug Eluting Stent is safe and effective. Superior to Taxus in historical comparison

11

MR Stent MR-MP Study SC-RCT

Wessely R et al 2007 (E Heart J) - Randomized Trial Rapamycin vs Paclitaxel Eluting Stent

91

9mFU, LLL 0.33mm vs 0.96mm, TLR 8.7% vs 26.7%, ST 0%

Both stent platforms proved safe. Rapamycin is more effective than Paclitaxel

12

MR Stent MASTER Study SC-Registry

Mehilli J., Kastrati A. 2010 (Final Report) - MASTER Study Two Year Results (Itrix vs Cypher)

224

2yFU, ST 0%, MACE 20.5%

The stent has an excellent safety and efficacy profile. Both lack of stent thrombosis and lack of late restenosis catch-up may suggest a benefit with this platform

13

MR Stent PILOT OCT Study SC-RCT

Tada T, Byrne R 2012 (DHZM Report) - PILOT - 4 months follow-up report, Tada T et al 2012 (JACC) - Differential Vascular Healing Patterns with biodegradable SES

15

4mFU, No ST, 0% >30% uc struts vs 28%, 0% map struts

MR stents were associated with enhanced vascular healing at 4 months

14

Aspiration Catheter

Multicentre trial

19

90% success rate in acute

Aspiration Catheter fulfils guideline for acute treatment in coronaries

Peripheral Vascular
No.

1

Device/Study

Balloon Expandable Peripheral Inert Stent

Report/Publication

Principal Investigator - Ivo Petrov, UH St. Ekaterina, Sofia, Bulgaria, 2003

Patients

94

Outcome

Overall restenosis 12.7%, 7.8% for locations without mechanical stress, TVR 8.5%

Result

The novel Balloon Expandable Peripheral Inert Stent has shown for its supposed and main indicated field an excellent outcome

2

Self-expanding peripheral stent POLARIS

MQ3 POLARIS REGISTRY Principal Investigator – Dr. Hans Krankenberg MD

95

Acute proce­dural success (≤30% stenosis and the absence of floe limiting dissection or major adverse events within 72 h of the index procedure, Peripheral Academic Research Consortium (PARC) (1) was achieved in 93.7% (74/79) of the patients, and procedural success (increase in ankle brachial index ≥0.1 from baseline) at 30 days in 86.2% (56/65). Averaged symp­tom classification changed from Rutherford category 2.8 at baseline to 0.3 at 30 days

We preliminar­ily conclude that the treatment of superficial femoral artery lesions with the POLARIS stent system in a real world setting is effec­tive up to 30 days. So far, no safety concerns were raised