CORONARY STENTS

- Bare Metal - Passive Coated - Drug Eluting - Covered

PERIPHERAL STENTS

BALLOON

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None of the products described on this website have been cleared by FDA for sale in the USA.


Commited to conducting clinical trials, Vascular Concepts has completed various trials and registries with Pronova in 2078 patients both in India and abroad. Following are the details of the clinical trials:

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Please Note:
None of the products described on this website have been cleared by FDA for sale in the USA.

ProNOVA

Abstracts

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Indian Heart Journal
Honorary Editor: Dr. V.K Bahl
All India Institute of Medical Sciences, New Delhi, India.

Issue #193

Results of Stenting using Very Long Pronova Stents

Amresh Kumar, Umesh Agrawal, Naveen Garg, Sudeep Kumar, Satyendra Tewari, Aditya Kapoor, PK Goel, Nakul Sinha
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

Significant reduction in instent restenosis and a need for repeat interventions has been shown by randomized controlled clinical trials of drug-eluting stents (DES). But data regarding the DES > 30 mm length is limited. We report our initial experience with very long (greater than or equal to 33 mm) Pronova stents. Between June 2004 and June 2005, a total of 870 coronary stenting procedures were performed, 31 patients belonged to this category. Mean age of the patients was 54.910.3 years (range: 41-68 years); 25 (80%) patients were males and 6 (20%) were females. Diabetes was present in 8 (26%), hypertension in 4 (13%), and smoking in 8 (26%) patients. The indications of angioplasty were chronic stable angina in 20 (64%), unstable angina in 8 (26%) and my ocardial infarction MI in 3 (10%) patients. Left anterior descending (LAD) was stented in 20 (64%) cases, left circumflex (LCx) in 5 (16%), and right coronary artery (RCA) in 6 (20%) cases. All lesions were pre-dilated and stents deployed at 12-14 atm pressure with an attempt to cover the lesion from one normal segment to another. The length of stent was 33 mm in 20 (64%) and 38 mm in 11 (36%) patients. The diameter of the stents was 2.75 mm, 3 mm and 3.5 mm in 6 (20%), 10 (32%) and 15 (48%) patients, respectively. The mean diameter of stents used was 3.110.37 mm. Eight (26%) patients received another stent in another vessel. Glycoprotein (Gp) IIb/IIIa antagonists were administered in 8 (26%) patients. All received aspirin as well as clopidogrel following the procedure. Immediate post-procedure results were excellent in all patients without any complication. None of the patients developed instent thrombosis. At a mean follow-up period of 6.83.5 months, there has been no instance of death/MI. One patient who was symptomatic and had positive treadmill test (TMT), underwent repeat coronary angiography which showed diffuse instent restenosis. It was successfully treated with plain balloon angioplasty. We conclude that angioplasty using very long Pronova DES stent is safe with good outcome on mid-term follow-up.

Indian Heart Journal
Honorary Editor: Dr. V.K Bahl
All India Institute of Medical Sciences, New Delhi, India.

Issue #172

Intermediate-Term Results of Long ProNova Stents

(>23 mm) - Results From Spandan Long ProNova Registry
HM Mardikar, NV Deshpande, Aziz Khan
Spandan Heart Institute and Research Center, Nagpur

Spandan long ProNova registry was conducted at our institute between June 2003 to April 2004 to assess safety and efficacy of long ProNova stents. Seventy-four patients were treated with long ProNova stents during this period. Of the 74 patients, 11 (14.8%) were suffering from chronic stable angina, 51 (68.9%) were suffering from unstable angina, 6 (8.1%) presented with acute myocardial infarction (MI) and 6 (8.1%) underwent rescue percutaneous transluminal coronary angioplasty (PTCA) for failed thrombolysis. Of the total population 31 (41.8%) were diabetic and 48 (64.86%) were suffering from hypertension. Eighty-five long lesions were treated in 74 patients with 90 long stents. Of 85 lesions,10 (11.7%) were total occlusions, 22 (25.8%) lesions were thrombotic and 49 (57.6%) were left anterior descending (LAD) lesions. Right coronary artery (RCA) was involved in 25 (29.4%) cases and left cirumflex artery (LCx) lesions were 11 (12.9%). Forty-eight patients received glycoprotein (Gp) IIb/ IIIA inhibitors before PTCA (40 eptifibatide and 8 abciximab). The mean lesion length was 26.24.7 mm and mean vessel size was 2.960.52 mm. Mean stent length used was 30.55.4 mm and mean stent diameter was 3.030.36 mm. Seven long lesions (>35 mm), were treated with 14 long overlapping stents. Intra-aortic balloon pump (IABP) `support was required in 3 patients. One patient died in-hospital following PTCA. No other major cardiac events were recorded pre-discharge. Of the 73 patients 69 were followed for 9.24.3 months. Four patients were lost to follow-up. Of the 69 patients, 3 patients underwent coronary artery bypass graft surgery (CABG) between 3 to 6 months following PTCA (6 months major adverse cardiac events (MACE) rate 4.3%.) Additionally 4 patients were complaining of exertional angina on moderate to severe exercise at follow-up. They have declined further invasive work-up as their angina does not limit dayto- day activity. Thus, implantation of long ProNova stents in real life cases is safe and effective with total MACE (inhospital+ 6months) rate of 5.4% at 6 months follow-up.

Indian Heart Journal
Honorary Editor: Dr. V.K Bahl
All India Institute of Medical Sciences, New Delhi, India.

Issue #138

Percutaneous Transluminal Coronary Angioplasty and Stenting with Drug-Eluting Stent and Follow-up: Single Centre Experience of Pronova Sirolimus-Eluting Stent

DK Baruah, M Srinivas NK Panigrahi
Apollo Hospital, Visakhapatnam

Restenosis is the major concern of percutaneous transluminal coronary angioplasty (PTCA) and drug-eluting stent (DES) has been able to reduce it to a significant extent. We reviewed 77 consecutive cases of PTCA with stenting using Pronova DES and immediate as well as 6 months follow-up results were analyzed. There were 63 (81.8%) males and 14 (18.2%) females with mean age of 559 years. Risk factors analysis revealed hypertension in 37 (48%), diabetes 23 (29.8%), tobacco use 8 (10.5%), hyperlipidemia 15 (19.4%), obesity 6 (7.8%) and family history of coronary artery disease (CAD) in 3 (3.4%). Forty-four (57.1%) cases presented with anterior wall myocardial infarition (AWMI), 18 (23.4%) inferior wall myocardial infarction (IWMI), 21 (27.3%) unstable angina and 10 (12.9%) cases with chronic stable angina; 62 (80%) cases had normal left ventricular (LV) function. Distribution of various arteries attempted were left anterior descending (LAD): 43 cases (55.8%), right coronary artery (RCA): 18 (23.3%), left circumflex (LCx): 15 (19.4%) and others 1 (1.3%). Type A lesions were in 1 (1.2%) patient, type B1 12 (14.3%), type B2 25 (29.8%) and type C in 36 (42.8%). Analysis of reference diameter of vessels revealed less than or equal to 2.5 mm in 19 (22.6%) patients, 2.6-3 mm in 50 (59.5%) and 3.1-3.5 in 15 (17.8%) patients. 84 stents were used in 77 cases with the rate of 1.09 stent per patient. The lesion lengths were analyzed and found to have less than or equal to 15 mm in 18 (21.4%) cases, 16-20 mm in 19 (27%) and > 20 mm in 39 (46.4%) cases. Technical success rate was 100%. There was no death. Two patients had immediate complication. Follow-up was carried by clinical review in hospital, telephonic information about clinical status, stress test and angiogram. Out of 77 cases, 58 (75.3%) cases could be followed up. Five (8.6%) cases were found to have restenosis and one patient died of MI. Other 4 cases underwent coronary angiogram and were sent for coronary artery bypass grafting (CABG) giving the target vessel revascualrization (TVR) rate of 6.9%. Out of those 5 cases, 2 cases underwent PTCA for restenosis in bare metal stent. Follow-up data of DES in India are not many. Although number of cases in our study was not enough to come to definite conclusion, it showed the trend of immediate and mid-term results of Pronova DES.