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 excellent 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
